Embotrap ET009533Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10886704081326), received between Aug 23, 2018 and Jul 1, 2025 — classified as 16 deaths, 89 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (29 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.

• DeathJul 1, 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 70-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF CONGESTIVE HEART FAILURE, ATRIAL FIBRILLATION, PREVIOUS ISCHEMIC STROKE (¿UN-UNK-2019¿), AND HYPERTENSION, PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2024 AT 01:30. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 08:30. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT 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 12 AND A MRS SCORE OF ¿1-NO SIGNIFICANT DISABILITY. ABLE TO CARRY OUT ALL USUAL DUTIES AND ACTIVITIES.¿ THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY ON (B)(6) 2024 USING AN EMBOTRAP II 5X33 REVASC. DEV. (ET007533/ 23E251AV) FOR AN OCCLUSION AT THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS RESULTED IN A MTICI SCORE OF 1, WITH CLOT RETRIEVAL IN THE STENT RETRIEVER. THE 2ND PASS RESULTED IN A MTICI SCORE OF 2A, WITH CLOT RETRIEVAL IN THE STENT RETRIEVER. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT

  Patient problems: Intracranial Hemorrhage; Stroke/CVA

  MAUDE report 22373912 ↗
• MalfunctionJun 9, 2025Fracture; Failure to Advance; Fracture; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY, AN EMBOTRAP II 5X33 REVASCULARIZATION DEVICE (ET007533, 24F077AV) WAS IMPEDED IN DISTAL END OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR ONLY RETRACTED THE STENT ALONE, AND FOUND THE DISTAL END OF THE STENT WAS DAMAGED. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. IT WAS NOTED THAT PRIOR TO THE PROCEDURE, THE STENT PACKAGING AND THE STENT WERE INSPECTED IN GOOD CONDITION. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-JUN-2025 INDICATED THAT THE INSERTION TOOL WAS SECURELY PLACED IN THE HUB OF THE MICROCATHETER PRIOR TO ATTEMPTING TO ADVANCE THE EMBOTRAP. THE RHV WAS TIGHTENED. THERE WAS NO DIFFICULTY FLUSHING THE DEVICE. THE DEVICE COULD BE ADVANCED THROUGH THE HUB. THERE WAS NO DAMAGE (I.E. KINK) IDENTIFIED ON THE MICROCATHETER. THE DEVICE WAS STILL ABLE TO MOVE WITHIN THE MICROCATHETER. TWO PASSES WERE MADE TO ATTEMPT TO RETRIEVE THE CLOT. THE VESSELS WERE ¿NORMAL¿. THE PROCEDURAL WAS DELAY/PROLONGED FOR ¿ABOUT 15 MINUTES¿ DUE TO THE EVENT. THE PROCEDURE PROLONGATION DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170971 ↗
• MalfunctionMay 12, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, AN EMBOTRAP II 5X33 REVASCULARIZARION DEVICE (ET007533, 24D167AV) COULD NOT BE ADVANCED IN THE IMPEDED INDEEP MICROCATHETER (MC). WITH A NEW DEVICE, THE PROCEDURE WAS SUCCESSFUL. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-MAR-2025 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. ANOTHER STENT RETRIEVER WAS USED SUCCESSFULLY WITH THE MICROCATHETER AFTER THE ENCOUNTERED RESISTANCE. IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THE DEVICE DID NOT APPEAR TO BE DAMAGED. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE OUTERCAGE ASSEMBLY IS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002278 ↗
• MalfunctionFeb 11, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A MECHANICAL THROMBECTOMY, AN EMBOTRAP II 5X33 REVASCULARIZATION DEVICE (ET007533, 24D167AV) IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO THE MICROCATHETER (MC). THE DOCTOR ONLY RETRACTED THE STENT ALONE AND OBSERVED DELIVERY WIRE OF THE STENT WAS KINKED/BENT. A NEW DEVICE WAS SWITCHED TO COMPLETE THE SURGERY. THE WELLPATH 0.021 MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 07-JAN-2025 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THERE WAS NO BREAK IN MATERIAL INTEGRITY AT THE SITE OF THE DEFECT, SUCH AS CRACKING OR FRACTURE. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE PROXIMAL COLLAR WAS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355936 ↗
• MalfunctionJan 9, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A MECHANICAL THROMBECTOMY, THE VESSEL WAS NOT COMPLETELY RECANALIZED AFTER THE COMPLETION OF THE FIRST THROMBUS ASPIRATION. THE PHYSICIAN INTENDED TO PERFORM THE SECOND THROMBUS ASPIRATION WITH THE SAME DEVICES, BUT THE EMBOTRAP II 5X33 REVASCULARIZATION DEVICE (ET007533, 23D202AV) WAS IMPEDED IN THE PROXIMAL OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, UNKNOWN LOT) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO A NEW STENT TO COMPLETE THE PROCEDURE WITH THE SAME MICROCATHETER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112876 ↗
• MalfunctionDec 12, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A MECHANICAL THROMBECTOMY, AN EMBOTRAP II 5X33 REVASCULARIZATION DEVICE (ET007533, 22A229AV) BECAME IMPEDED WHEN THE STENT TIP PASSED A PROWLER SELECT PLUS 150/5CM MICROCATHETER TIP (A SHORT SECTION), AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915153 ↗
• InjuryOct 18, 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 75-YEAR-OLD MALE (SUBJECT (B)(6) WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE, DIABETES, PREVIOUS ISCHEMIC STROKE (¿UN-MAR-2024¿), HYPERCOAGULABLE STATE, HYPERTENSION, AND ACTIVE SMOKING, PRESENTED WITH AN UNKNOWN STROKE TYPE ON AN UNKNOWN DATE. DETAILS OF THIS PATIENT¿S BASELINE STROKE EVENT WERE NOT MADE AVAILABLE AT THE TIME OF THIS REVIEW. THE PATIENT¿S BASELINE NIHSS SCORE WAS 20 AND MODIFIED RANKIN SCALE SCORE (MRS) SCORE WAS ¿2-SLIGHT DISABILITY; UNABLE TO CARRY OUT ALL PREVIOUS ACTIVITIES, BUT ABLE TO LOOK AFTER OWN AFFAIRS WITHOUT ASSISTANCE.¿ ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOTRAP II 5X33 REVASC. DEV. (ET007533 / 23K057AV). DETAILS OF THIS PROCEDURE WERE NOT MADE AVAILABLE AT THE TIME OF THIS REVIEW. IT IS UNKNOWN IF THERE WERE ANY INTRAOPERATIVE STUDY DEVICE DEFICIENCIES. ON (B)(6) 2024, THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 17. ON (B)(6) 2024, THE PATIENT EXPERIENCED THE EVENT OF ¿BLEEDING IN THE LEFT BASEMENT AREA,¿ WHICH BECAME KNOWN TO THE SITE ON THE SAME DAY AND TO THE SPONSOR ON 29-SEP-2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED

  Patient problems: Intracranial Hemorrhage

  MAUDE report 20481899 ↗
• MalfunctionSep 9, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A MECHANICAL THROMBECTOMY, EMBOTRAP II 5X33 REVASCULARIZATION DEVICE (ET007533, 23E251AV) BECAME IMPEDED IN THE DISTAL END OF PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO A NEW MICROCATHETER TO USE DELIVERY OF THE SAME EMBOTRAP, BUT IT HAD THE SAME PROBLEM. THE PHYSICIAN ONLY RETRACTED THE STENT AND SWITCHED A NEW STENT (OTHER BRAND) TO COMPLETE THE SURGERY. THE SECOND MICROCATHETER WAS NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170316 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE FOR AN ACUTE ISCHEMIC STROKE (AIS) ON AN UNKNOWN DATE, THE PHYSICIAN USES THE EMBOTRAP FREQUENTLY ON A DAILY BASIS, ¿SO NO PROBLEM WITH ITS USE OR TECHNIQUE.¿ THE MECHANICAL THROMBECTOMY PROCEDURE WAS TARGETING AN M2 OCCLUSION USING A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533 / LOT# UNKNOWN). THE THROMBUS WAS SUCCESSFULLY RETRIEVED, BUT POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) IMAGES SHOWED MINOR BLEEDING. THE ASYMPTOMATIC INTRACRANIAL HEMORRHAGE OCCURRED AND NO SPECIAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ASYMPTOMATIC AND WAS PLACED UNDER OBSERVATION. THE PATIENT WAS THEN REPORTED TO BE DISCHARGED FROM THE HOSPITAL ¿ON A LATER DATE, AFTER GOOD IMPROVEMENT WAS OBSERVED.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PHYSICIAN COMMENTED THAT ¿THERE IS CAUSAL RELATIONSHIP BETWEEN THE ISSUE AND THE PRODUCT. THE ISSUE COULD BE OCCURRED BECAUSE THE EMBOTRAP WAS USED AT THE TORTUOUS M2 LESION. ALSO, ENDOTHELIAL DAMAGE BY THE ASPIRATION CATHETER COULD BE OCCURRED.¿ THE EMBOTRAP II DEVICE WAS USED IN ACCORDANCE WITH THE INS

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17213810 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE FOR AN ACUTE ISCHEMIC STROKE (AIS) ON AN UNKNOWN DATE, THE PHYSICIAN USES THE EMBOTRAP FREQUENTLY ON A DAILY BASIS, ¿SO NO PROBLEM WITH ITS USE OR TECHNIQUE.¿ THE MECHANICAL THROMBECTOMY PROCEDURE WAS TARGETING AN M2 OCCLUSION USING A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533 / LOT# UNKNOWN). THE THROMBUS WAS SUCCESSFULLY RETRIEVED, BUT POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) IMAGES SHOWED MINOR BLEEDING. THE ASYMPTOMATIC INTRACRANIAL HEMORRHAGE OCCURRED AND NO SPECIAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ASYMPTOMATIC AND WAS PLACED UNDER OBSERVATION. THE PATIENT WAS THEN REPORTED TO BE DISCHARGED FROM THE HOSPITAL ¿ON A LATER DATE, AFTER GOOD IMPROVEMENT WAS OBSERVED.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PHYSICIAN COMMENTED THAT ¿THERE IS CAUSAL RELATIONSHIP BETWEEN THE ISSUE AND THE PRODUCT. THE ISSUE COULD BE OCCURRED BECAUSE THE EMBOTRAP WAS USED AT THE TORTUOUS M2 LESION. ALSO, ENDOTHELIAL DAMAGE BY THE ASPIRATION CATHETER COULD BE OCCURRED.¿ THE EMBOTRAP II DEVICE WAS USED IN ACCORDANCE WITH THE INS

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17213801 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE FOR AN ACUTE ISCHEMIC STROKE (AIS) ON AN UNKNOWN DATE, THE PHYSICIAN USES THE EMBOTRAP FREQUENTLY ON A DAILY BASIS, ¿SO NO PROBLEM WITH ITS USE OR TECHNIQUE.¿ THE MECHANICAL THROMBECTOMY PROCEDURE WAS TARGETING AN M2 OCCLUSION USING A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533 / LOT# UNKNOWN). THE THROMBUS WAS SUCCESSFULLY RETRIEVED BY MULTIPLE PASSES, BUT POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) IMAGES SHOWED MINOR BLEEDING. THE ASYMPTOMATIC INTRACRANIAL HEMORRHAGE OCCURRED AND NO SPECIAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ASYMPTOMATIC AND WAS PLACED UNDER OBSERVATION. THE PATIENT WAS THEN REPORTED TO BE DISCHARGED FROM THE HOSPITAL ¿ON A LATER DATE, AFTER GOOD IMPROVEMENT WAS OBSERVED.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PHYSICIAN COMMENTED THAT ¿THERE IS CAUSAL RELATIONSHIP BETWEEN THE ISSUE AND THE PRODUCT. THE ISSUE COULD BE OCCURRED BECAUSE THE EMBOTRAP WAS USED AT THE TORTUOUS M2 LESION. ALSO, ENDOTHELIAL DAMAGE BY THE ASPIRATION CATHETER COULD BE OCCURRED.¿ THE EMBOTRAP II DEVICE WAS USED IN ACCO

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17213792 ↗
• MalfunctionMar 22, 2023Fracture; Material Twisted/Bent; Premature Separation; Fracture; Material Twisted/Bent; Premature Separation

  IT WAS REPORTED THAT THE COMPLAINT DEVICE, A 5MM X 21MM EMBOTRAP II REVASCULARIZATION DEVICE (ET007521 / 20F098AV) WAS USED DURING A PRODUCT PRESENTATION IN FLUID MODEL TO DEMONSTRATE THE THROMBECTOMY PROCESS AND THE SIMULATED THROMBUS WAS PLACED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PHYSICIAN REMOVED THE EMBOTRAP II DEVICE TOGETHER WITH THE INTERMEDIATE CATHETER OUT FROM THE FLUID MODEL AND IT WAS IMMEDIATELY OBSERVED THAT THE STENT BODY AND THE DELIVERY WIRE WERE KINKED / BENT. IT WAS REPORTED THAT THEN, THE WHOLE STENT BODY FELL OFF FROM THE DELIVERY WIRE; THE INNER AND OUTER CAGES / CHANNELS OF THE STENT BODY WERE SEPARATED. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS A PRODUCT PRESENTATION. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT. ON 16-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CERENOVUS SALES REPRESENTATIVE VIA PHONE. THE INFORMATION INDICATED THAT THE MICROCATHETER USED WITH THE EMBOTRAP II DEVICE WAS A MICROPORT MICROCATHETER. A SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION) WAS USED. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. DURING ADVANCEMENT, THE PHYSICIAN ENCOUNTERED SIGHT RESISTANCE AT THE TORTUOUS END O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595177 ↗
• DeathNov 17, 2022Entrapment of Device; Patient-Device Incompatibility; Entrapment of Device; Patient-Device Incompatibility

  THE REPORTED EVENT WAS IDENTIFIED VIA THE MAUDE DATABASE INVOLVING A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533 / LOT# UNKNOWN). A 92-YEAR-OLD PATIENT UNDERWENT A THROMBECTOMY PROCEDURE WHERE THE 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE WAS USED. IT WAS REPORTED THAT ¿ON THE 4TH PASS, THE EMBOTRAP II DEVICE WAS APPROXIMATELY 2/3 INTO THE WALRUS 087 BALLOON GUIDE CATHETER (Q¿APEL) (BG8087-095 / FG22011J-02) WHEN IT BECAME ENTANGLED.¿ THE PHYSICIAN REMOVED BOTH THE WALRUS BALLOON GUIDE CATHETER AND THE EMBOTRAP II DEVICE FROM THE PATIENT. IT WAS REPORTED THAT THE 92-YEAR-OLD PATIENT EXPIRED POST-PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 15821187 ↗
• DeathSep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY, A 64-YEAR-OLD FEMALE (SUBJECT 934-072) WITH A MEDICAL HISTORY OF HYPERCOAGULABLE STATE, SMOKING, AND COLON CANCER PRESENTED WITH AN ACUTE ISCHEMIC STROKE ON AN UNKNOWN DATE WITH NIHSS SCORE OF 27 AND MRS SCORE OF 0. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS A HYPERCOAGULABLE STATE DUE TO UNDERLYING MALIGNANCY. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533/ 20D088AV) DEVICE ON (B)(6) 2020. THE FIRST PASS WAS MADE WITH THE EMBOTRAP DEVICE AT THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) RESULTING IN AN MTICI SCORE OF 0 WITH NO CLOT RETRIEVAL. A CEREBASE GUIDE CATHETER WAS USED DURING THIS PASS. THE SECOND AND THIRD PASSES WERE ALSO MADE WITH THE EMBOTRAP DEVICE AT THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE SECOND PASS RESULTED IN AN MTICI SCORE OF 2B WITH CLOT RETRIEVAL IN THE STENT RETRIEVER AND THE THIRD PASS RESULTED IN AN MTICI SCORE OF 2A WITH NO CLOT RETRIEVAL. THE FOURTH AND FIFTH PASSES WERE MADE WITH A 4MM X 30MM TREVO STENT RETR

  Patient problems: Insufficient Information

  MAUDE report 15361257 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A (B)(6) PATIENT UNDERWENT MECHANICAL THROMBECTOMY OF A MIDDLE CEREBRAL ARTERY OCCLUSION WITH A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533/UNKNOWN LOT NUMBER) AND EXPERIENCED SUBARACHNOID HEMORRHAGE (SAH) SECONDARY TO VESSEL DISSECTION DURING THE PROCEDURE. THE BALLOON GUIDE CATHETER WAS INFLATED, AND THE BLOOD FLOW WAS BLOCKED, RESULTING IN HEMOSTASIS OF THE BLEEDING SITE. THE PROCEDURE WAS COMPLETED. THE M2 SUPERIOR TRUNK OF THE MCA REMAINS OCCLUDED. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN. CONCOMITANT DEVICES INCLUDED A 9F OPTIMO BALLOON GUIDE CATHETER (TOKAI MEDICAL), CATALYST 6 ASPIRATION CATHETER (STRYKER), AND A PHENOM 21 MICROCATHETER (MEDTRONIC). THROMBUS REMOVAL WAS PERFORMED FOR CEREBRAL INFARCTION USING THE ABOVE-MENTIONED DEVICES. THE CATALYST 6 WAS POSITIONED IN THE INTERNAL CAROTID (IC) TOP AND THE PHENOM 21 MICROCATHETER WAS REGIONALLY CROSSED TO ACCESS THE M2 SUPERIOR TRUNK. FROM THERE, THE EMBOTRAP DEVICE WAS POSITIONED AND DEPLOYED. THE TREATING PHYSICIAN WAS ABLE TO CAPTURE A SMALL AMOUNT OF THROMBUS, BUT AN OCCLUSION REMAINED AT THE M2 SUPERIOR TRUNK. THE OCCLUDED REGION WAS REGIONALLY CROS

  MAUDE report 13769493 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLD FOR BG 4.19THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT UNDERWENT A MECHANICAL THROMBECTOMY OF A MIDDLE CEREBRAL ARTERY (MCA) M2 SEGMENT OCCLUSION WITH A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533 / 21G174AV) AND EXPERIENCED BLEEDING AFTER THE EMBOTRAP II DEVICE WAS RETRIEVED. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED.

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

  MAUDE report 13737144 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT UNDERWENT MECHANICAL THROMBECTOMY OF AN INTERNAL CAROTID (IC) TOP OCCLUSION WITH A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533 / 21G174AV) AND EXPERIENCED INTRAOPERATIVE IC RE-OCCLUSION AND THROMBOEMBOLISM TO THE DISTAL M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE EMBOTRAP II DEVICE WAS DEPLOYED FROM THE DISTAL M1 FOR IC TOP OCCLUSION. A REACT¿ SUCTION CATHETER (MEDTRONIC) WAS ENGAGED AT THE PROXIMAL END OF THE THROMBUS, AND CONTINUOUS ASPIRATION PRIOR TO INTRACRANIAL VASCULAR EMBOLECTOMY (CAPTIVE) TECHNIQUE WAS PERFORMED. A LARGE AMOUNT OF RED THROMBUS WAS REMOVED FROM THE IC AFTER FIRST PASS. RESIDUAL THROMBUS WAS NOTED AT THE DISTAL M1 (UNKNOWN WHETHER IT WAS RELEASED FROM IC OR ORIGINALLY TANDEM OCCLUSION). A SECOND PASS WAS MADE WITH THE EMBOTRAP II; HOWEVER, THE THROMBUS WAS NOT REMOVED. THE IC THEN RE-OCCLUDED. A SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC) WAS USED FOR THE THIRD PASS. ¿A LOT OF THROMBUS¿ WAS NOT RETRIEVED, BUT THE IC BLOOD FLOW RESUMED. THE DISTAL M1 REMAINED OCCLUDED. THE PHYSICIAN PERFORMED ANOTHER PASS WITH THE SOLITAIRE AT THE DISTAL M1, BUT THE THROMBUS WAS NOT REMOVED. THE PROCEDURE WA

  Patient problems: Obstruction/Occlusion; Thromboembolism

  MAUDE report 13387745 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PATIENT UNDERWENT MECHANICAL THROMBECTOMY OF A MIDDLE CEREBRAL ARTERY (MCA) (M2 SEGMENT) OCCLUSION WITH A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533/UNKNOWN LOT NUMBER) AND EXPERIENCED BLEEDING. THE EXACT TIMING OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BLEEDING WAS NOTED AT THE M2 SEGMENT OF THE MCA. THE COMPLAINT DEVICE WAS ALLEGEDLY USED AS PER THE INSTRUCTIONS FOR USE (IFU); HOWEVER, THE HEMORRHAGE WAS CONFIRMED WHEN IT WAS USED IN CONJUNCTION WITH THE ASPIRATION CATHETER (BRAND/MANUFACTURER UNKNOWN). ONLY ONE PASS WAS MADE WITH THE DEVICE. THERE WAS NO PARALYSIS DUE TO THE HEMORRHAGE; THE PATIENT¿S BASELINE CLINICAL SYMPTOMS WERE UNCHANGED. NO ADDITIONAL TREATMENT WAS PROVIDED. AFTER THAT, ANTICOAGULATION WAS PRESCRIBED BECAUSE RE-OCCLUSION HAD OCCURRED. HOWEVER, THE ANTICOAGULATION TREATMENT WAS DELAYED DUE TO THE HEMORRHAGE. THERE WAS NO EXTENSION OF THE HOSPITAL STAY AS A RESULT OF THE EVENT. THE PHYSICIAN COMMENTED THAT THE HEMORRHAGE MUST HAVE OCCURRED DUE TO RETRACTION OF THE STENT RETRIEVER. THE BLEED WAS NOT CONSIDERED SERIOUS BECAUSE SYMPTOMS HAD NOT WORSENED. AD

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 13176433 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PATIENT UNDERWENT MECHANICAL THROMBECTOMY OF A MIDDLE CEREBRAL ARTERY (MCA) (M2 SEGMENT) OCCLUSION WITH A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533/UNKNOWN LOT NUMBER) AND EXPERIENCED BLEEDING AT THE M2 REGION. THE PATIENT HAS BEEN MONITORED IN THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 13051900 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PATIENT UNDERWENT MECHANICAL THROMBECTOMY OF A LEFT MIDDLE CEREBRAL ARTERY (MCA) (M1 SEGMENT) OCCLUSION WITH AN 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533/UNKNOWN LOT NUMBER). AFTER A 9F OPTIMO BALLOON GUIDE CATHETER (TOKAI MEDICAL) WAS ADVANCED TO THE LEFT INTERNAL CAROTID ARTERY (ICA), A CAT 6 ASPIRATION CATHETER (STRYKER) WAS ¿CRIMPED¿ TO THE THROMBUS WITH A TREVO TRAK 21 MICROCATHETER (STRYKER). THE EMBOTRAP II WAS ¿DEVELOPED FROM M2¿, AND THE THROMBUS WAS REMOVED USING COMBINED TECHNIQUE. THE TARGET VESSEL WAS RECANALIZED DURING THE FIRST PASS, BUT THE ¿LUCENCY IMAGE OF THROMBUS WAS CONFIRMED IN THE LEFT M1 DISTAL¿. BECAUSE THE THROMBUS HAD INCREASED, ASPIRIN 200 MG AND CLOPIDOGREL 300 MG WERE INJECTED VIA GASTRIC TUBE; DRIP INFUSION OF OZAGREL 80 MG WAS ADDED. THE THROMBUS HAD ALMOST DISAPPEARED WITHIN 40 MINUTES, AND THE PROCEDURE WAS SCHEDULED TO BE COMPLETED. HOWEVER, WHEN THE 9F LONG SHEATH (BRAND NOT SPECIFIED) IN THE RIGHT FEMORAL ARTERY WAS REPLACED WITH A SHORT SHEATH, THE PATIENT FLEXED HIS/HER FOOT, AND THE SHORT SHEATH WAS NOT ABLE TO BE PLACED IN THE FEMORAL ARTERY. IMMEDIATELY AFTER THAT, THE PATI

  Patient problems: Thromboembolism

  MAUDE report 12993942 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A (B)(6) FEMALE PATIENT UNDERWENT MECHANICAL THROMBECTOMY OF AN INTERNAL CAROTID ARTERY (ICA) TO MIDDLE CEREBRAL ARTERY (MCA) (M2 SEGMENT) OCCLUSION WITH A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533/21E091AV) AND EXPERIENCED A SLIGHT CEREBRAL INFARCTION AFTER THE PROCEDURE. THE TARGET VESSEL WAS FULLY RECANALIZED WITH THREE DEVICE PASSES, HOWEVER, SLIGHT INFARCTION WAS CONFIRMED BY COMPUTED TOMOGRAPHY (CT) SCAN FOLLOWING THE PROCEDURE. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE EVENT WAS NOT CONSIDERED SERIOUS. CONCOMITANT DEVICES INCLUDED A 9F OPTIMO BALLOON GUIDE CATHETER (TOKAI MEDICAL) AND A TRAK 21 MICROCATHETER (STRYKER). THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Ischemia Stroke

  MAUDE report 12984386 ↗
• InjuryDec 8, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A MECHANICAL THROMBECTOMY OF A MIDDLE CEREBRAL ARTERY (MCA) (M3 SEGMENT) OCCLUSION, THE PHYSICIAN ENCOUNTERED DIFFICULTY WITHDRAWING THE 5MM X 3MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533/UNKNOWN LOT NUMBER) FROM THE PATIENT. EXTRAVASATION OCCURRED AS A RESULT OF THE EVENT. THE EXTRAVASATION WAS TREATED WITH HEMOSTATIC MEDICINE AND BLOOD PRESSURE CONTROL. THE EVENT DID NOT LEAD TO PROLONGED HOSPITALIZATION. THE PHYSICIAN STATED THAT ¿BECAUSE IT WAS DEVELOPED IN M3, THE BLOOD VESSEL USED WAS NOT APPROPRIATE. THE PATIENT HAD PARALYSIS AT BASELINE, AND THE EXTRAVASATION DID NOT AFFECT THE PATIENT¿S CLINICAL OUTCOME. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 12963983 ↗
• InjuryDec 8, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A MECHANICAL THROMBECTOMY OF A MIDDLE CEREBRAL ARTERY (MCA) (M3 SEGMENT) OCCLUSION, THE PHYSICIAN ENCOUNTERED DIFFICULTY WITHDRAWING THE 5MM X 3MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533/UNKNOWN LOT NUMBER) FROM THE PATIENT. EXTRAVASATION OCCURRED AS A RESULT OF THE EVENT. THE EXTRAVASATION WAS TREATED WITH HEMOSTATIC MEDICINE AND BLOOD PRESSURE CONTROL. THE EVENT DID NOT LEAD TO PROLONGED HOSPITALIZATION. THE PHYSICIAN STATED THAT ¿BECAUSE IT WAS DEVELOPED IN M3, THE BLOOD VESSEL USED WAS NOT APPROPRIATE. THE PATIENT HAD PARALYSIS AT BASELINE, AND THE EXTRAVASATION DID NOT AFFECT THE PATIENT¿S CLINICAL OUTCOME.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 12961830 ↗
• MalfunctionDec 6, 2021Difficult to Remove; Difficult to Remove

  THE HEALTHCARE PROFESSIONAL REPORTED THAT AT A PRODUCT ROUND TABLE DISCUSSION ON 16-NOV-2021, IT WAS REPORTED THAT THE 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533 / LOT# UNKNOWN) ENCOUNTERED DIFFICULTY DURING THE ATTEMPT TO WITHDRAWAL IT THROUGH THE VESSEL. IT WAS NOT KNOWN IF CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12936810 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE (B)(6) FEMALE PATIENT WITH A HISTORY OF ATHEROSCLEROSIS UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE WITH THE TARGET OCCLUSION IN THE MIDDLE CEREBRAL ARTERY (MCA) WITH A 5MM X 33MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009533 / 21B021AV); THE PATIENT EXPERIENCED A SUBARACHNOID HEMORRHAGE (SAH) ON THE FOLLOWING DAY. LEAKAGE OF CONTRAST MEDIUM WAS ALSO NOTED ON THE COMPUTED TOMOGRAPHY (CT) IMAGING. THE PATIENT EXHIBITED APHASIA DUE TO THE EVENT. NO INTERVENTION WAS PROVIDED. THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT HER PROGNOSIS WAS GOOD AND SHE HAD NO PROBLEMS IN HER DAILY LIFE. THERE IS NO PARTICULAR PLAN FOR FUTURE TREATMENT. THE PHYSICIAN COMMENTED THAT THE RELATIONSHIP OF THE EMBOTRAP II DEVICE TO THE REPORTED EVENT IS UNKNOWN; ATHEROSCLEROSIS WAS A POSSIBLE ROOT CAUSE OTHER THAN THE DEVICE. IT WAS REPORTED THAT THE EMBOTRAP WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU). RECANALIZATION WAS ACHIEVED WITH ONE PASS OF THE EMBOTRAP. THERE WERE REPORTEDLY NO ISSUES WITH THE THROMBUS REMOVAL, AND THE PROCEDURE WAS COMPLETED SAFELY. THE BLOOD VESSEL ¿DID NOT FEEL PULLED¿ AND THERE WAS NO LEAKAGE OF CONTRAS

  Patient problems: Intracranial Hemorrhage

  MAUDE report 12929535 ↗