N/A IC71132UGRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10886704082378), received between Feb 27, 2020 and Aug 14, 2025 — classified as 2 deaths, 27 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 65-YEAR-OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF HYPERTENSION AND ATRIAL FIBRILLATION, PRESENTED WITH AN UNWITNESSED WAKE-UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2024 AT 22:30. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2024 AT 06:30. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 10:53, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 27 AND THE MODIFIED RANKIN SCALE SCORE (MRS) SCORE WAS ¿0-NO SYMPTOMS.¿ ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN UNKNOWN THROMBECTOMY NEURAVI DEVICE (PRODUCT CODE/LOT # UNKNOWN). DETAILS OF THIS PROCEDURE WERE NOT MADE AVAILABLE AT THE TIME OF THIS REVIEW. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS ASSESSMENT SCORE WAS 3. ON (B)(6) 2024, THE PATIENT EXPERIENCED THE EVENT OF ¿RE-OCCLUSION OF M2¿, WHICH WAS MADE KNOWN TO THE SITE AND SPONSOR ON (B)(6) 2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS A SERIOUS, SEVERE ADVERSE EVENT THAT WAS UNR

  Patient problems: Vascular Dissection

  MAUDE report 22804455 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 76-YEAR-OLD FEMALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF HYPERLIPIDAEMIA, AND HYPERTENSION, PRESENTED WITH AN UNWITNESSED STROKE NON-WAKE UP. LAST TIME SEEN WELL WAS ON (B)(6) 2023, AT 07:45. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2023, AT 08:00. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023, AT 09:28,, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿ARTERY TO ARTERY (TANDEM LESION WITH PROXIMAL ICA STENOSIS AND INTRACRANIAL OCCLUSION).¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 22 AND MODIFIED RANKIN SCALE (MRS) SCORE OF ¿0- NO SYMPTOMS.¿ ON (B)(6) 2023, THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY USING AN EMBOVAC 132CM LARGE BORE 71 CATHETER (IC71132UG/ (B)(6)) FOR AN OCCLUSION AT THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THERE WAS UNDERLYING ICAD (INTRACRANIAL ATHEROSCLEROTIC DISEASE) AT THE OCCLUSION SITES. THE ADDITIONAL INTERVENTION PERFORMED AFTER THE FIRST THROMBECTOMY PASS WAS ¿PROXIMAL CAROTID ATHEROSCLEROTIC LESION ANGIOPLASTY, AND PROXIMAL C

  Patient problems: Obstruction/Occlusion

  MAUDE report 22804107 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY ((B)(4)), A 42-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF HYPERTENSION, AND ACTIVE SMOKER, PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2023, AT 11:40. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023, AT 13:23, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED AT THE TIME OF STROKE PRESENTATION, AT 14:09. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿LARGE-ARTERY DISEASE (INTRACRANIAL ATHEROSCLEROSIS).¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 16 AND MODIFIED RANKIN SCALE (MRS) SCORE OF ¿0- NO SYMPTOMS.¿ ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOTRAP III 5 MM X 37 MM (ET309537/ 23B074AV) AND A 132CM EMBOVAC LARGE BORE 71 CATHETER (IC71132UG/ 30805056) FOR OCCLUSION SITE AT THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THERE WAS UNDERLYING ICAD (INTRACRANIAL ATHEROSCLEROTIC DISEASE) AT THE OCCLUSION SITES. THE PRE-PASS MTICI SCORE WAS 0. THE FIRST PASS WAS MADE USING EMBOTRAP DEVICE WHICH RESULTED IN A MTICI SCORE OF 2C, WITH CLOT RETRIEVAL IN THE STENT-RETRIEVER. DURING THE PROCEDURE A GUIDEWIRE WA

  Patient problems: Obstruction/Occlusion

  MAUDE report 22458273 ↗
• InjuryJun 30, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  AS REPORTED VIA THE EXCELLENT STUDY (CNV_2017_02), A 61-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF HYPERLIPIDAEMIA AND HYPERTENSION, AND ACTIVE SMOKER, PRESENTED WITH AN UNWITNESSED STROKE ON AN UNKNOWN DATE AND TIME. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023, TIME UNKNOWN, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿SMALL-VESSEL DISEASE.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 11 AND MODIFIED RANKIN SCALE (MRS) SCORE OF ¿0- NO SYMPTOMS.¿ ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN 132CM EMBOVAC LARGE BORE 71 CATHETER (IC71132UG/ 31054024) FOR OCCLUSIONS AT THE M1 AND M2 SEGMENTS OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE FIRST TWO PASSES WERE MADE USING A DIRECT CONTACT ASPIRATION DEVICE ALONE AT THE M1 RIGHT OCCLUSION SITE, WHICH RESULTED IN A MTICI SCORE OF 2B, WITH CLOT RETRIEVAL FOR THE 1ST PASS ONLY. THE THIRD PASS WAS MADE AT THE M2 RIGHT OCCLUSION SITE, WHICH RESULTED IN A MTICI SCORE OF 2B, WITH NO CLOT RET

  Patient problems: Obstruction/Occlusion

  MAUDE report 22360095 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 77-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF TRANSIENT ISCHEMIC ATTACK (TIA) PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2024 AT 12:45 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 18:21 HOUR, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿CARDIOEMBOLIC.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 13 AND THE MODIFIED RANKIN SCALE MRS SCORE WAS ¿0-NO SYMPTOMS.¿ ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR THROMBECTOMY PROCEDURE USING A 132 CM EMBOVAC LARGE BORE 71 CATHETER (IC71132UG / 31171175) THAT TARGETED OCCLUSION IN THE M1 AND M2 SEGMENTS OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS WAS DONE AT THE M1 SITE USING THE EMBOVAC DIRECT CONTACT ASPIRATION ALONE, RESULTING IN A MTICI SCORE OF 2B, WITH CLOT RETRIEVAL IN THE ASPIRATE. FOR THE SECOND PASS, DEVICES WERE EXCHANGED DUE TO ¿VESSEL SIZE. THE 2ND PASS WAS DONE AT THE M2 SITE USING AN AXS CATALYST® CATHETER (STRYKER) DIRECT CONTACT ASPIRATION ALONE, RESULTING

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22207774 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), AN 84-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF ATRIAL FIBRILLATION, DIABETES, HYPERLIPIDEMIA, & HYPERTENSION, PRESENTED WITH AN UNWITNESSED NON-WAKE-UP STROKE. THE LAST TIME SEEN WELL WAS ON (B)(6) 2023 AT 22:00. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2023, TIME UNKNOWN. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023 AT 12:53, WHERE MRI IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF THE STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿CARDIOEMBOLIC.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 15 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS ¿0 - NO SYMPTOMS.¿ ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOVAC IC 71, 132 CM, CE, ASP. IND. (IC71132CA/(B)(6)) FOR AN OCCLUSION AT THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE FIRST PASS WAS MADE USING THE EMBOVAC DEVICE, WHICH RESULTED IN A MTICI SCORE OF 3, WITH CLOT RETRIEVAL. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE BRAND WAS NOT SPECIFIED. A 0.021 TREVO MICROCATHETER

  Patient problems: Obstruction/Occlusion

  MAUDE report 21928921 ↗
• InjuryFeb 18, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN EMBOVAC IC 71, 132 CM, CE, ASP. IND. (IC71132CA/ 31163781) WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED IMPEDIMENT OF THE EMBOVAC DEVICE WITH NO LOSS OF CEREBRAL TARGET POSITION. THE DEVICE WAS THEN EXCHANGED FOR A NEW EMBOVAC DEVICE. THE EVENT RESULTED IN A FIVE-MINUTE PROCEDURAL DELAY. THE EVENT WAS REPORTED AS SUCH, ¿EMBOVAC DID NOT FIT THROUGH EMBOGUARD 87 95CM. NEW EMBOVAC (DIFFERENT LOT NUMBER) WAS TAKEN AND DID FIT. PROCEDURAL TIME WAS EXTENDED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS PROLONGED BY 5 MINS AS A RESULT OF THE DIFFICULTY ENCOUNTERED WITH THE DEVICE.¿ ON 30-JAN-2025, ADDITIONAL INFORMATION WAS RECEIVED. SUMMARY: PER THE INFORMATION, THE REPORTED FIVE-MINUTE DELAY WAS CONSIDERED TO BE CLINICALLY SIGNIFICANT. THE TARGET VESSEL IS UNKNOWN. NO RELEVANT ANATOMICAL INFORMATION WAS PROVIDED. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE EMBOGUARD. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401192 ↗
• MalfunctionSep 25, 2024Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, AN EMBOVAC CATHETER (IC71132CA, 31098757) WAS KINKED FROM THE DISTAL TIP ZONE. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE BODY/SHAFT WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302773 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (CNV_2017_02), A (B)(6) FEMALE (SUBJECT (B)(6) WITH A HISTORY OF ATRIAL FIBRILLATION, PRESENTED WITH A WITNESSED STROKE ON 08-AUG-2024 AT 12:10. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 14:00. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿CARDIOEMBOLIC¿. THE PATIENT¿S BASELINE NIHSS SCORE WAS 27 AND AN MRS SCORE OF ¿4-MODERATELY SEVERE DISABILITY. UNABLE TO WALK WITHOUT ASSISTANCE AND UNABLE TO ATTEND TO OWN BODILY NEEDS WITHOUT ASSISTANCE.¿ ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOVAC LARGE BORE CATHETER (PRODUCT CODE/ LOT # UNKNOWN). DETAILS OF THIS PROCEDURE WERE NOT MADE AVAILABLE AT THE TIME OF THIS REVIEW. ON (B)(6) 2024, THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 22. ON 12-AUG-2024, THE PATIENT EXPERIENCED THE EVENT OF A ¿SYMPTOMATIC INTRACEREBRAL HEMORRHAGE,¿ WHICH BECAME KNOWN TO THE SITE ON THE SAME DAY AND TO THE SPONSOR ON 26-AUG-2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS A SEVERE BUT NOT SERIOUS ADVERSE EVENT, AND AS UNRELATED TO

  Patient problems: Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156529 ↗
• MalfunctionAug 28, 2024Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), A STENT (UNSPECIFIED COMPETITOR BRAND) WAS DELIVERED INTO THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) AFTER IT AND THE EMBOVAC LARGE BORE 71 CATHETER (IC71132UG / 31242244) WERE IN PLACE. THE STENT WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN REMOVED THE STENT, MICROCATHETER, AND THE EMBOVAC LBC FROM THE PATIENT. IT WAS OBSERVED THAT THE EMBOVAC WAS BROKEN (CRACKED, NOT DETACHED). THE PHYSICIAN REPLACED IT WITH A NEW INTERMEDIATE CATHETER (UNSPECIFIED COMPETITOR BRAND) AND USED THE SAME STENT AND MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 23-AUG-2024, PER THE CERENOVUS SALES REPRESENTATIVE, ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE CANNOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091118 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT IS REPORTED VIA THE EXCELLENT STUDY ¿ THE 69-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF CONGESTIVE HEART FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIABETES, HISTORY OF ISCHEMIC STROKE, HYPERLIPIDEMIA, HYPERTENSION, AND SMOKING (ACTIVE), PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. THE LAST TIME HE WAS SEEN WELL WAS ON (B)(6) 2024, AT 08:00 HOUR. SYMPTOMS WERE FIRST OBSERVED ON THE SAME DAY AT 18:00 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 21:19. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿. THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY PROCEDURE ON (B)(6) 2024. THE EMBOVAC LARGE BORE 71 CATHETER (IC71132UG / 31171175) WAS USED TO TARGET AN OCCLUSION IN THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE FIRST PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE, WHICH RESULTED IN A MTICI SCORE OF 0, WITH NO CLOT RETRIEVAL. THE SECOND PASS WAS MADE USING A SOLITAIRE STENT-RETRIEVER, WHI

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19941701 ↗
• InjuryAug 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 76-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF ATRIAL FIBRILLATION AND CONGESTIVE HEART FAILURE, PRESENTED WITH AN UNWITNESSED WAKE-UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2024 AT 21:00. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2024 AT 04:11. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 05:28, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 7 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS ¿0-NO SYMPTOMS.¿ ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN UNKNOWN EMBOVAC DEVICE (PRODUCT CODE/ LOT # UNKNOWN) FOR AN OCCLUSION AT THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS RESULTED IN A MTICI SCORE OF 3, WITH CLOT RETRIEVAL. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE BRAND WAS NOT SPECIFIED. AN 8 BOBBY BALLOON GUIDE WAS ALSO USED. THERE WERE NO STUDY DEVICE DEFICIENCIES DURING THE PROCEDURE.

  Patient problems: Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19883954 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (CNV_2017_02), A 58-YEAR-OLD FEMALE (B)(6) WITH A MEDICAL HISTORY OF HYPERTENSION, PERIPHERAL ARTERY DISEASE, AND SMOKING (ACTIVE), PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. LAST TIME SEEN WELL WAS ON 11-JUL-2024 AT 12:00. SYMPTOMS WERE FIRST OBSERVED ON THE SAME DAY AT 12:30. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON 11-JUL-2024 AT 13:55. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 20 AND A MRS SCORE OF ¿3-MODERATE DISABILITY. REQUIRES SOME HELP, BUT ABLE TO WALK WITHOUT ASSISTANCE.¿ ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN UNKNOWN EMBOVAC/CERENOVUS LARGE BORE CATHETER (LBC) (PRODUCT CODE/ LOT # UNKNOWN) FOR AN OCCLUSION AT THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST AND 2ND PASSES WERE MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE, WHICH RESULTED IN A MTICI SCORE OF 0, WITH NO CLOT RETRIEVAL FOR BOTH PASSES. DUE TO PERSISTENT CLOT, THE 3RD PASS WAS MADE US

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19861875 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 61-YEAR-OLD MALE (SUBJECT (B)(6) WITH A MEDICAL HISTORY OF HYPERTENSION, PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2024 AT 09:00. SYMPTOMS WERE FIRST OBSERVED ON (B)(6)2024 AT 09:30. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 19:17, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 12 AND MODIFIED RANKIN SCALE SCORE MRS SCORE WAS ¿1-NO SIGNIFICANT DISABILITY. ABLE TO CARRY OUT ALL USUAL DUTIES AND ACTIVITIES.¿ ON (B)(6)2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOVAC IC 71, 132 CM, CE, ASP. IND. LARGE BORE CATHETER (IC71132UG/ 31247203) FOR AN OCCLUSION AT THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE, WHICH RESULTED IN A MTICI SCORE OF 2B, WITH NO CLOT RETRIEVAL. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE B

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19784139 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 71-YEAR-OLD MALE PATIENT WITH A HISTORY OF DEEP VEIN THROMBOSIS (DVT) AND PERIPHERAL ARTERY DISEASE (PAD), PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2024 AT 08:00 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024, TIME UNKNOWN. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 10. THE MODIFIED RANKIN SCALE (MRS) WAS NOT AVAILABLE AT THE TIME OF THE COMPLAINT INITIATION / REVIEW. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOVAC LARGE BORE 71 CATHETER (IC71132UG / 31202405) TARGETING OCCLUSIONS IN THE LEFT INTERNAL CAROTID ARTERY (ICA) AND THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE FIRST PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE AT THE ICA SITE, WHICH RESULTED IN A MTICI SCORE OF 0, WITH CLOT RETRIEVAL. THE SECOND PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE AT THE M2 SITE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19751417 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 57-YEAR-OLD FEMALE (B)(6) WITH A MEDICAL HISTORY OF DIABETES AND HYPERTENSION, PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. LAST TIME SEEN WELL WAS ON 16-JUN-2024 AT 15:20. SYMPTOMS WERE FIRST OBSERVED ON 16-JUN-2024 AT 16:50. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 16:50. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 22 AND A MRS SCORE OF ¿0-NO SYMPTOMS.¿ ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN 132CM LARGE BORE 71 CATHETER (IC71132UG, 31247203). DETAILS OF THIS PROCEDURE WERE NOT MADE AVAILABLE AT THE TIME OF THIS REVIEW. THERE WERE NO INTRAOPERATIVE STUDY DEVICE DEFICIENCIES. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 16. ON 18-JUN-2024, THE PATIENT EXPERIENCED THE ADVERSE EVENT OF ¿SMALL FOCUS OF SUBARACHNOID HEMORRHAGE,¿ WHICH BECAME KNOWN TO THE SITE AND SPONSOR ON 21-JUN-2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS NOT SERIOUS, MILD IN SEVERITY, AND AS NOT RELATED

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19724408 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), AN 84-YEAR-OLD MALE (B)(6) WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) AND HYPERTENSION, PRESENTED WITH AN UNWITNESSED WAKE-UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2024 AT 00:00. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2024 AT 09:00. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 14:42. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 29 AND A MRS SCORE OF ¿1-NO SIGNIFICANT DISABILITY. ABLE TO CARRY OUT ALL USUAL DUTIES AND ACTIVITIES.¿ ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN UNKNOWN EMBOVAC DEVICE (PRODUCT CODE/ LOT # UNKNOWN). DETAILS OF THIS PROCEDURE WERE NOT MADE AVAILABLE AT THE TIME OF THIS REVIEW. THERE WERE NO INTRAOPERATIVE STUDY DEVICE DEFICIENCIES. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 22. ON (B)(6) 2024, THE PATIENT EXPERIENCED THE ADVERSE EVENT OF ¿PETECHIAL HEMORRHAGE IN THE PARENCHYMAL AND SUBARACHNOID SPACE,¿ WHICH BECAME KNOWN TO THE SITE AND SPONSOR ON (B)(6) 202

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19710201 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY (B)(6), AN 86-YEAR-OLD MALE ((B)(6)) WITH A HISTORY OF DIABETES AND DEEP VEIN THROMBOSIS, PRESENTED WITH AN UNWITNESSED WAKE UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2024 AT 02:00. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2024 AT 06:00. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 09:02, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿CARDIOEMBOLIC¿. THE PATIENT¿S BASELINE NIHSS SCORE WAS 24 AND MODIFIED RANKIN SCALE SCORE MRS SCORE WAS ¿0- NO SYMPTOMS¿. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING A 132CM LARGE BORE 71 CATHETER (IC71132UG/31032506) FOR AN OCCLUSION AT THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE AND RESULTED IN A MTICI SCORE OF 2C, WITH CLOT RETRIEVAL IN THE ASPIRATE. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE BRAND WAS NOT SPECIFIED. A 0.021 PNOVUS21 MICROCATHETER AND AN 8 BOBBY BALLOON GUIDE WERE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19703345 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY ((B)(6)), A 66-YEAR-OLD MALE (SUBJECT (B)(6) WITH A MEDICAL HISTORY OF DIABETES, HISTORY OF TRANSIENT ISCHEMIC ATTACK (DATE UNKNOWN), AND HYPERTENSION, PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2024 AT 10:30. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 11:21. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿OTHER ETIOLOGIES: ECAD¿ (POSSIBLY MEANING INTRACRANIAL ATHEROSCLEROTIC DISEASE ICAD). THE PATIENT¿S BASELINE NIHSS SCORE WAS 26 AND A MRS SCORE OF ¿0-NO SYMPTOMS.¿ THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY ON (B)(6) 2024 USING AN EMBOVAC 132CM LARGE BORE 71 CATHETER (IC71132UG/ 31242244). DETAILS OF THIS PROCEDURE WERE NOT MADE AVAILABLE AT THE TIME OF THIS REVIEW; HOWEVER, IT WAS DISCLOSED THAT THE FINAL/END OF PROCEDURE MTICI SCORE WAS 3. THERE WERE NO REPORTED INTRAOPERATIVE STUDY DEVICE DEFICIENCIES. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 12. ON (B)(6) 2024, THE PATIENT EXPERIENCED THE ADVERSE EVENT OF ¿PETECHIAL BLOOD PRODUCTS,¿ WHICH BECAME KNOWN TO THE SITE AND SPONSOR ON 05-JUN-20

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19701485 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 52-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION, DIABETES, DEEP VEIN THROMBOSIS AND FORMER SMOKER, PRESENTED WITH UNWITNESSED NON-WAKE UP STROKE. THE PATIENT WAS LAST SEEN WELL ON (B)(6) 2023 AT 15:45 HOUR. HER SYMPTOMS WERE FIRST OBSERVED ON THE SAME DAY, THE TIME WAS NOT KNOWN. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023 AT 22:04. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿CARDIOEMBOLIC.¿ THE PATIENT¿S BASELINE NIH STROKE SCALE/SCORE (NIHSS) WAS 22 AND A MODIFIED RANKIN SCALE (MRS) SCORE OF ¿0-NO SYMPTOMS.¿ ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOVAC LARGE BORE 71 CATHETER (IC71132UG / 31032506) FOR AN OCCLUSION IN THE LEFT CAROTID T. THE PRE-PASS MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE 1ST PASS RESULTED IN A MTICI SCORE OF 3, WITH CLOT RETRIEVAL. A GUIDEWIRE (UNSPECIFIED BRAND), A VELOCITY® DELIVERY MICROCATHETER (PENUMBRA) AND A WALRUS BALLOON CATHETER (Q¿APEL) WERE ALSO USED DURING THE PROCEDURE. THERE WERE NO

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19697616 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 06-MAY-2024, THE PATIENT EXPERIENCED THE EVENT OF ¿TRACE PETECHIAL BLOOD PRODUCTS,¿ WHICH WAS MADE KNOWN TO THE SITE AND SPONSOR ON 17-MAY-2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS NOT SERIOUS, MILD IN SEVERITY, AND AS UNRELATED TO THE EMBOTRAP STUDY DEVICE (NOT USED), POSSIBLY RELATED TO THE LARGE BORE CATHETER, UNRELATED TO THE CEREGLIDE71 (NOT USED), AND UNRELATED TO THE PRIMARY SURGICAL PROCEDURE. THE EVENT DID NOT REQUIRE A MEDICAL INTERVENTION AND THE OUTCOME IS RECORDED AS ¿RECOVERING/RESOLVING,¿ WITH NO END DATE LISTED. THE INFORMATION ENTERED IN THE CASE REPORT FORM, CRF, IS RE-REVIEWED. PROCEDURE AND PATIENT DETAILS ARE AS FOLLOWS: THE PATIENT IS A 59-YEAR-OLD FEMALE (B)(6) WITH A MEDICAL HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), HYPERLIPIDEMIA, AND HYPERTENSION, AND PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. LAST TIME SEEN WELL WAS ON 30-APR-2024 AT 17:00. SYMPTOMS WERE FIRST OBSERVED ON 01-MAY-2024, TIME UNKNOWN. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON 01-MAY-2024 AT 20:43, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRES

  Patient problems: Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467752 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 85-YEAR-OLD MALE PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION AND HYPERTENSION, PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. THE LAST TIME THE PATIENT WAS SEEN WELL WAS ON (B)(6) 2024 AT 02:30 HOUR. SYMPTOMS WERE FIRST OBSERVED ON THE SAME DAY AT 09:30 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 15:53 HOUR, WHERE COMPUTED TOMOGRAPHY (CT) IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS OF ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 25 AND MODIFIED RANKIN SCALE SCORE (MRS) SCORE WAS ¿0-NO SYMPTOMS.¿ THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOVAC LARGE BORE 71 CATHETER (IC71132UG / 31171175) FOR AN OCCLUSION IN THE M2 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) WAS 0. THE FIRST PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE, WHICH RESULTED IN A MTICI SCORE OF 3, WITH CLOT RETRIEVAL IN THE ¿ASPIRATE.¿ A GUIDEWIRE (UNSPECIFIED

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19448970 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 62-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPERLIPIDEMIA, HYPERTENSION, AND ACTIVE SMOKING, PRESENTED WITH AN UNWITNESSED WAKE-UP STROKE. SHE WAS LAST SEEN WELL ON (B)(6) 2024 AT 01:00 HOUR. SYMPTOMS WERE FIRST OBSERVED ON THE SAME DAY AT 04:15 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 09:35 HOUR, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 23 AND MODIFIED RANKIN SCALE SCORE MRS SCORE WAS ¿0-NO SYMPTOMS.¿ THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY ON (B)(6) 2024 USING AN EMBOVAC LARGE BORE CATHETER (CATALOG / LOT# UNKNOWN) TARGETING AN OCCLUSION IN THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE FIRST PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE, WHICH RESULTED IN AN MTICI SCORE OF 3, WITH CLOT RETRIEVAL IN THE ¿ASPIRATE.¿ THERE WERE NO STUDY DEVICE DEFICIENC

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19256402 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 74-YEAR-OLD FEMALE PATIENT PRESENTED WITH AN UNWITNESSED WAKE-UP STROKE. SHE WAS LAST SEEN WELL ON 15-APR-2024 AT 21:00 HOUR. SYMPTOMS WERE FIRST OBSERVED ON 16-APR-2024 AT 07:00 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON 16-APR-2024 AT 08:21 HOUR, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES: EMBOLIC STROKE OF UNDETERMINED SOURCE.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 21 AND MODIFIED RANKIN SCALE SCORE (MRS) SCORE WAS ¿0-NO SYMPTOMS.¿ THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY ON (B)(6)2024 USING AN EMBOVAC LARGE BORE 71 CATHETER (IC71132UG / 3117175 ¿ THIS LOT NUMBER IS PENDING VERIFICATION WITH THE STUDY SITE) TARGETING AN OCCLUSION IN THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE FIRST TWO PASSES WERE MADE USING THE EMBOVAC DIRECT CONTACT ASPIRATION DEVICE ALONE, WHICH RESULTED IN A MTICI SCORE OF 2B, WITH CLOT RETRIEVAL IN THE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19256376 ↗
• MalfunctionFeb 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 67-YEAR-OLD FEMALE PATIENT PRESENTED WITH A LEFT M1 STROKE UNDERWENT A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE AN EMBOVAC LARGE BORE 71 CATHETER (IC71132UG / 31117548) WAS USED WITH A 4MM X 41MM TREVO NXT¿ STENT RETRIEVER (STRYKER) AND THE TIP OF THE EMBOVAC LBC WAS DAMAGED AFTER ONE PASS. IT WAS REPLACED WITH ANOTHER EMBOVAC LARGE BORE 71 CATHETER (IC71132UG) FROM THE SAME LOT (31117548) WHICH WAS ALSO DAMAGED AFTER A SECOND PASS WITH THE STENT RETRIEVER. TWO APRO¿* 70 ASPIRATION CATHETERS (MEDTRONIC) WERE USED EITHER DAMAGED OR FAILED, BUT ANOTHER (A THIRD) EMBOVAC LARGE BORE 71 CATHETER WAS USED SUCCESSFULLY AND THE CLOT WAS RETRIEVED / REMOVED RESULTING IN A TICI SCORE OF 3. IT WAS REPORTED THAT PER THE LEAD TECH, ¿IT WAS DIFFICULT ANATOMY AND THE PHYSICIAN HAD SAID TO BAG THE 2 LARGE BORE CATHETERS FOR A COMPLAINT.¿ THE DISTAL TIPS LOOK DAMAGED FROM CAN BE DISCERNED IN THE BAGS. THE PATIENT WAS REPORTED TO BE FINE POST-PROCEDURE. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED AS A RESULT OF THE REPORTED ISSUES. ON 04-JAN-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION. ¿THERE WAS NO BREAK OR FRACTURE OF [THE] TIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754945 ↗