EMBOTRAP ET309645Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10886704082859), received between Oct 22, 2021 and Jul 7, 2025 — classified as 5 deaths, 30 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (19 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE INTERNAL CAROTID ARTERY (ICA) TO TREAT A CEREBRAL INFARCTION, THE DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). THE 6.5MM X 45MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309645 / 24L143AV) WAS PREPARED AND INTRODUCED INTO THE CONCOMITANT PHENOM¿ MICROCATHETER (MEDTRONIC). AFTER CROSSING THE LESION, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, BUT A STRONG RESISTANCE WAS FELT INSIDE THE MICROCATHETER; CONTINUOUS FLUSH WAS MAINTAINED. THE EMBOTRAP III DEVICE WAS REMOVED FROM THE PATIENT¿S ANATOMY AND THE STENT COMPONENT WAS OBSERVED TO BE DEFORMED. IT WAS REPLACED WITH ANOTHER 6.5MM X 45MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309645) WHICH WAS USED WITHOUT ANY ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE IMPACT TO THE PATIENT. ON 27-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE REPORTED ISSUE WITH THE EMBOTRAP III DEVICE DID OCCUR ON THE FIRST PASS. ON 07-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE SAME ORIGINAL PHENOM MICROCATHETER WAS USED WITH THE SECOND EMBO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22430378 ↗
• InjuryMay 6, 2025Adverse 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 66-YEAR-OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF ISCHEMIC STROKE, HYPERLIPIDEMIA, AND HYPERTENSION PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2023. IT IS CURRENTLY UNKNOWN WHEN THE PATIENT WAS LAST SEEN WELL. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE DAY AFTER (APPROXIMATELY 3H50M AFTER THE FIRST SYMPTOMS). 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 OF 9 AND MRS SCORE OF 0. THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY ON (B)(6) 2022 USING A 6.5MM X 45MM EMBOTRAP III (ET307645/ 22E175AV) DEVICE FOR AN OCCLUSION AT THE VERTEBROBASILAR SYSTEM (CRF STATES OCCLUSION AT THE BASILAR AND VERTEBRAL ARTERIES). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS (2 MIN INCUBATION TIME) RESULTED IN A MTICI SCORE OF 1 WITH CLOT RETRIEVAL. AT THE 2ND AND 3RD PASS, A DIRECT CONTACT ASPIRATION WAS ATTEMPTED ONLY USING THE INTERMEDIATE/ASPIRATION CATHETER USED IN CONJUNCTION WITH THE EMBOTRAP III A

  Patient problems: Obstruction/Occlusion

  MAUDE report 21967838 ↗
• MalfunctionApr 22, 2025Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY, AN EMBOTRAP III 6.5 MM X 45 MM (ET309645, 24K240AV) AND AN INTRODUCER SHEATH WAS FLUSHED ON BACK TABLE. THE TECHNICIAN DID NOT REPORT THAT THE EMBOTRAP WAS VISUALLY INSPECTED PRIOR TO USE. THE EMBOTRAP INTRODUCER SHEATH WAS INSERTED INTO THE UNSPECIFIED MICROCATHETER (MC). THE EMBOTRAP WAS ADVANCED THROUGH THE MC AND 1 PASS WAS MADE WITH THE EMBOTRAP. THE PHYSICIAN REMOVED THE EMBOTRAP FROM THE CATHETER AND HANDED IT TO THE TECHNICIAN TO CLEAN TO MAKE A SECOND PASS. THE TECHNICIAN NOTED SOME CLOT WITHIN THE EMBOTRAP BUT NOTICED THE PROXIMAL END APPEARED BENT/"DAMAGED". THE USER PULLED A SECOND EMBOTRAP TO BE USED. CASE PROCEEDED WITHOUT AN EVENT. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-MAR-2025 CLARIFIED THAT THE BENT/DAMAGE APPEARED TO BE IN THE TAPERED AREA OF THE PROXIMAL 2 RADIOPAQUE MARKERS. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. THE PATIENT HAD A CLOT THAT EXTENDED FROM THE RIGHT ARM UP TO THE MIDDLE CEREBRAL ARTERY (MCA). THERE WAS NO BREAK IN MATERIAL INTEGRITY AT THE SITE OF THE DEFECT, SUCH AS CRACKING OR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885555 ↗
• MalfunctionMar 4, 2025Break; Break

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING MECHANICAL THROMBECTOMY PROCEDURE, THE 6.5MM X 45MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309645 / 24J081AV) ¿GOT BROKEN.¿ IT WAS REPLACED WITH ANOTHER THE 6.5MM X 45MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309645) FROM THE SAME LOT NUMBER (24J081AV) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. CONTINUOUS FLUSH WAS NOT KNOWN. DETAILS RELATED TO THE DEVICE AND THE PROCEDURE ARE STILL PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520975 ↗
• MalfunctionFeb 21, 2025Break; Retraction Problem; Break; Retraction Problem

  AS REPORTED BY THE FIELD, THIS WAS A MECHANICAL THROMBECTOMY OF THE RIGHT INTERNAL CAROTID ARTERY TO TREAT ACUTE ISCHEMIC STROKE (ACI). AFTER INSERTING OPTIMO 8FR GUIDING CATHETER, CAT6 INTERMEDIATE CATHETER AND PHENOM 21 MICROCATHETER (MC), THE EMBOTRAP III 6.5 MM X 45 MM REVASCULARIZATION DEVICE (ET309645, 24J081AV) WAS DELIVERED, AND THE THROMBUS WAS CAPTURED. USING THE PINCHING TECHNIQUE, THE THROMBUS WAS CAUGHT BETWEEN THE MICROCATHETER AND THE EMBOTRAP III AND ATTEMPTED TO WITHDRAW INTO THE OPTIMO, BUT THERE WAS STRONG RESISTANCE AT THE TIP AND IT COULD NOT BE DRAWN IN. THE MICROCATHETER WAS ADVANCED AGAIN, BUT IT WAS NOT POSSIBLE TO COMPLETE RE-SHEATH THE CATHETER. ALTHOUGH THERE WAS RESISTANCE WHEN THE EMBOTRAP III WAS RETRIEVED AGAIN WITH HALF DEPLOYED, THE EMBOTRAP III WAS FORCIBLY PULLED INTO OPTIMO AND WITHDRAWN FROM THE PATIENT'S BODY. AS THE EMBOTRAP III WAS FOUND TO BE DAMAGED, IT WAS NOT REINSERTED. THE THROMBUS WAS ASPIRATED FROM OPTIMO AND THE RECANALIZATION WAS ACHIEVED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. A CHIKAI14 GUIDEWIRE WAS ALSO USED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 13-FEB-2025 INDICATING THAT THE DAMAGE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433185 ↗
• MalfunctionFeb 6, 2025Break; Failure to Advance; Break; Failure to Advance

  AS REPORTED BY THE FIELD, THIS WAS A MECHANICAL THROMBECTOMY OF THE INTERNAL CAROTID ARTERY (ICA) FOR CEREBRAL INFARCTION. AFTER THE BALLOON GUIDING CATHETER WAS ADVANCE INTO THE INTERNAL CAROTID ARTERY, RED68 REPERFUSION CATHETER AND PHENOM27 MICROCATHETER WERE ADVANCED INTO THE OCCLUDED AREA AND CROSSED THE LESION. WHEN THE EMBOTRAP III 6.5 MM X 45 MM THROMBUS RETRIVER (ET309645, 24C158AV) WAS DELIVERED USING THE PHENOM27, THE EMBOTRAP BECAME STUCK IN THE PHENOM27 AND COULD NOT BE DELIVERED. THE EMBOTRAP AND PHENOM27 WERE RETRIEVED. AFTER THAT, THE USER REPLACED THE PHENOM27 AND EMBOTRAP WITH NEW ONES. THE EMBOTRAP WAS DEPLOYED IN THE OCCLUDED AREA AND RETRIEVED, AND RECANALIZATION WAS ACHIEVED. CAROTID ARTERY STENTING WAS PERFORMED IN THE STENOTIC ARE OF THE ICA AND THE PROCEDURE WAS COMPLETED. THERE WAS NO IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE OPTIMO8FR FLEX GUIDING CATHETER, CHIKAI14 GUIDEWIRE, PHENOM MICROCATHETER, RED68 CATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-FEB-2025 INDICATED THAT NO PASSES WERE MADE. THE EMBOTRAP COULD NOT DELIVERED TO THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322446 ↗
• MalfunctionJan 16, 2025Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A MECHANICAL THROMBECTOMY, AN EMBOTRAP III THROMBUS RETRIEVER 6.5 MM X 45 MM (ET307645, 22E057AV) PUSHER WIRE KINKED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE DISTAL COIL MARKERS ARE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172801 ↗
• InjuryDec 26, 2024Retraction Problem; Material Separation; Retraction Problem; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE PHYSICIAN ADVANCED A FILTER WIRE ASPIRATION CATHETER AND A 6.5MM X 45MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309645 / 24C158AV) INTO THE CAROTID ARTERY. AFTER BALLOON ANGIOPLASTY, THE FILTER AND THE EMBOTRAP III WERE RECAPTURED HALFWAY INTO CATHETER. THE PHYSICIAN WAS UNABLE TO GET BOTH DEVICES INTO THE CATHETER AND MADE A DECISION TO BREAK THE EMBOTRAP III WHICH REMAINED IN THE PATIENT. THE PHYSICIAN WAS ABLE TO GET THE FILTER WIRE OUT. THE PHYSICIAN SUBSEQUENTLY PROCEEDED TO DEPLOY TWO MORE CAROTID STENTS. THE PATIENT IS REPORTED TO BE ¿DOING VERY WELL.¿ ON 16-DEC-2024, LIMITED INFORMATION WAS RECEIVED. PER THE INFORMATION, THE DEVICE WILL BE RETURNED FOR FURTHER ANALYSIS. NO FURTHER INFORMATION WILL BE MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020128 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/ 24F121AV) AND A 132CM CEREGLIDE 71 CATHETER (NIC71132C/ 31294255) WERE USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). A TOTAL OF FOUR PASSES WERE MADE. DETAILS OF THE PROCEDURE ARE AS FOLLOWS, ¿THE 1ST AND THE 2ND PASS WERE MADE TO M1 OCCLUSION SITE BY COMBINED TECHNIQUE WITH USING THE EMBOTRAP III, PHENOM27, THE CEREGLIDE 71 AND OPTIMO BUT RECANALIZATION WAS NOT ACHIEVED. THE 3RD PASS WAS MADE BY ADAPT WITH USING THE CEREGLIDE 71 AND OPTIMO, AS CROSSING THE CLOT BY MICROCATHETER WAS NOT FEASIBLE AT THIS TIME. DURING THE THROMBUS RETRIEVAL, THE PROXIMAL PART OF THE THROMBUS WAS TORN OFF AND REMOVED, BUT THE DISTAL RESIDUAL OF THROMBUS WAS LEFT IN M1. THE 4TH PASS WAS MADE BY USING DOUBLE STENT RETRIEVERS. TWO MICROCATHETERS (PHENOM21 AND TREVO TRAK 21) WERE INSERTED. THE EMBOTRAP III AND A SOLITAIRE 4*40 WERE DELIVERED AND DEPLOYED PARALLEL AT THE M1 OCCLUSION SITE AND RETRACTED.¿ AFTER THE FOURTH PASS WAS DONE USING DOUBLE STENT RETRIEVER TECHNIQUE, ANGIOGRAPHY CONFIRMED AN INTRACRANIAL HEMORRHAGE. THE PATIENT WAS TR

  Patient problems: Intracranial Hemorrhage

  MAUDE report 20887010 ↗
• MalfunctionDec 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, WHEN THE PHYSICIAN REMOVED THE 6.5MM X 45MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309645 / 24G058AV) AFTER HE MADE THE FIRST PASS, AND HE NOTICED THAT THE DEVICE ¿MAY HAVE HAD SOME OF THE COATING FLAKING OFF.¿ THE PHYSICIAN SET ASIDE THE DEVICE AND OPENED A NEW DEVICE TO USE FOR THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 04-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS ON (B)(6) 2024. IT WAS TARGETING THE LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS. THE CLOT WAS A LARGE FIBRIN RICH HYPERDENSE CLOT. THE TARGET VESSEL HAD MILD TO MODERATE TORTUOSITY. THERE WAS NO PHYSICAL DAMAGE TO THE STENT / CAGE ASSEMBLY. THE DAMAGE REPORTED WAS CLARIFIED AS ¿ABOUT 2 CM PROXIMAL TO THE PROXIMAL RADIOPAQUE 20MM COIL¿ FLAKED OFF. THE CONCOMITANT MICROCATHETER USED WAS A PHENOM¿ 21 MICROCATHETER (MEDTRONIC). THE REPLACEMENT DEVICE WAS ANOTHER 6.5MM X 45MM EMBOTRAP III DEVICE (ET309645). THE INFORMATION ALSO CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847977 ↗
• MalfunctionNov 11, 2024Retraction Problem; Retraction Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE TECHNICIAN TRIED TO GET THE 6.5MM X 45CM EMBOTRAP III REVASCULARIZATION DEVICE (ET309645 / LOT# UNKNOWN) OUT OF THE SOFIA¿ INTERMEDIATE CATHETER (TERUMO NEURO) AND IT WAS STUCK INSIDE THE SOFIA CATHETER. IT WAS REPORTED THAT THE SOFIA CATHETER WAS ¿BUCKLING / ACCORDIONING) WHEN THEY WHEN TRYING TO RETRIEVE THE EMBOTRAP III DEVICE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 29-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOT NUMBER OF THE EMBOTRAP III DEVICE IS UNKNOWN. THE LOT NUMBER OF THE DEVICE PRESENT AT THE SITE AT THE TIME OF THE REPORTED EVENT WAS 24F121AV. THE THROMBECTOMY PROCEDURE WAS TARGETING THE LEFT INTERNAL CAROTID ARTERY (ICA). THERE WAS SOME BEND IN THE ARCH. THE CLOT IS OF UNKNOWN LENGTH AND THE DENSITY IS OF RED BLOOD CELLS. THE EMBOTRAP III DEVICE HAD MADE 2 PASSES WHEN THE ISSUE OCCURRED: ON THE SECOND PASS. THE ISSUE OCCURRED OUTSIDE OF THE PATIENT¿S ANATOMY, DURING THE CLOSING OF THE CASE. THE FOLLOWING IS THE SEQUENCE OF EVENTS THAT LED UP TO THE REPORTED WITHDRAWAL DIFFICULTY: A. THEY CLIMB UP USING CEREBASE, DIAGNOSTIC CATHETER AND WITH PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20659918 ↗
• MalfunctionNov 6, 2024Retraction Problem; Material Separation; Retraction Problem; Material Separation

  AS REPORTED BY THE FIELD, DURING A MECHANICAL THROMBECTOMY, A CEREBASE GS 90, 90 CM GUIDE CATHETER (GS9090SD, 31332448) WAS FOUND KINKED AT THE HUB AFTER TRYING TO GET THE ASPIRATION CATHETER (SOFIA PLUS) AND THE EMBOTRAP III 6.5 MM X 45 MM (ET309645, 24F121AV). WHEN THEY TRIED TO GET THE EMBOTRAP OUT FROM THE SOFIA PLUS, IT WAS STUCK, AND THEY WERE NOT ABLE TO GET IT OUT. SOFIA ELONGATED AND THE TIP OF THE EMBOTRAP BECAME SEPARATED FROM THE STENT RETRIEVER ON THE TABLE. UNCLEAR IF THE SOFIA ELONGATED BEFORE OR AFTER THE ATTEMPT TO GET THE STENT RETRIEVER OUT AND IF THE CEREBASE WAS KINKED BEFORE OR AFTER THE PROBLEMATIC TO GET EVERYTHING OUT OF THE SYSTEM. THE CAROTID WAS HIGHLY CLOG BY SCLEROSIS AND SEEM TO BE RE CLOSING ITSELF AFTER WE NOTICED THE ISSUE WITH THE PRODUCTS. THE SURGERY WAS DELAYED BY 5 MINUTES DUE TO THE EVENT. DEVICES WERE CHANGED AND A NEURO MAX CATHETER AND A NEW SOFIA PLUS WERE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 28-OCT-2024 INDICATING THAT THE FIVE MINUTES PROCEDURAL DELAY WAS NOT SIGNIFICANT SINCE THEY WERE DOING THE CLINICAL EVALUATION OF THE FIRST PASS RESULTS AND CAROTID STATE. ONE PASS WAS ATTEMPTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621072 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT A 132CM CEREGLIDE 71 CATHETER (NIC71132C / LOT # UNKNOWN) AND AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/ LOT # UNKNOWN) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED THE EVENT OF "THROMBOEMBOLISM" OCCURRED WHILE USING BOTH DEVICES. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF COMMON CAROTID ARTERY OCCLUSION (CCA). FIRST, MANUAL ASPIRATION WAS CONDUCTED AT CCA [COMMON CAROTID ARTERY] BY USING A 9FR BGC [BALLOON GUIDE CATHETER], AND A LARGE AMOUNT OF RED THROMBUS WAS ASPIRATED. ALSO, A CEREGLIDE 71 WAS ADVANCED DISTALLY AND ADAPT [DIRECT ASPIRATION, FIRST PASS TECHNIQUE] WAS PERFORMED. THE CCA WAS RECANALIZED. THE PHYSICIAN SUSPECTED THAT THE LESION IN CAROTID ARTERY STILL MIGHT HAVE BEEN OCCLUDED BY SOME POTENTIAL FLOWED THROMBI FROM THE CCA. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE POTENTIAL THROMBI BY USING AN EMBOTRAP 6.5MMX45MM AND THE 9FR BGC. THE EMBOTRAP WAS DEPLOYED, AND ASPIRATION WAS CONDUCTED BY 9FR BGC. A LARGE AMOUNT OF RED THROMBUS WAS ASPIRATED AGAIN. FINALLY, EXTERNAL CAROTID ARTERY WAS FOUND TO BE OCCLUDED, WHICH WAS SUSPECTED THAT THROMBUS

  Patient problems: Thromboembolism

  MAUDE report 20525677 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT A 132CM CEREGLIDE 71 CATHETER (NIC71132C / LOT # UNKNOWN) AND AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/ LOT # UNKNOWN) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED THE EVENT OF A THROMBOEMBOLISM OCCURRED WHILE USING BOTH DEVICES FOR THE FIRST PASS. DURING THE SECOND PASS, THROMBOEMBOLISM OCCURRED WHILE USING THE CEREGLIDE71 CATHETER ALONE. THE FINAL MTICI SCORE WAS 2B (GREATER OR EQUAL TO 50% REPERFUSION). IT WAS REPORTED THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY. THE CEREGLIDE 71 WAS USED AS ACCESS CATHETER, EMBOTRAP III 6.5MM-45MM WAS USED AS STENT RETRIEVER. OCCLUSION WAS FOUND AT IC-TOP (DISTAL INTERNAL CAROTID ARTERY). AS THE VESSEL WAS SEVERELY ARTERIOSCLEROSIS, IT WAS DIFFICULT TO ADVANCE GUIDING CATHETER. 1ST PASS: THE EMBOTRAP III WAS DEPLOYED AND ASPIRATED BY CEREGLIDE 71. THROMBUS WAS RETRIEVED FROM THE LESION, BUT AN OCCLUSION WAS FOUND ON THE DISTAL SIDE. 2ND PASS: ACCESS CATHETER WAS ADVANCED AGAIN AND ADAPT [DIRECT ASPIRATION, FIRST PASS TECHNIQUE] WAS CONDUCTED. A LARG

  Patient problems: Thromboembolism

  MAUDE report 20509141 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/ LOT # UNKNOWN) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED A HEMORRHAGE OCCURRED. DETAILS OF THE PROCEDURE ARE CURRENTLY PENDING. THE PATIENT¿S POST-PROCEDURE STATUS IS UNKNOWN. CONTINUOUS FLUSH WAS UNKNOWN. THE LESION WAS UNKNOWN. OTHER CONCOMITANT DEVICES ARE ALSO UNKNOWN. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY USING EMBOTRAP III. HEMORRHAGE OCCURRED DURING THE PROCEDURE. THE DETAILS TO BE CONFIRMED. CONTINUOUS FLUSH WAS UNKNOWN. THE LESION WAS UNKNOWN. OTHER CONCOMITANT DEVICES WERE UNKNOWN.¿

  Patient problems: Intracranial Hemorrhage

  MAUDE report 20324367 ↗
• MalfunctionSep 3, 2024Entrapment of Device; Entrapment of Device

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE INTERNAL CAROTID ARTERY (ICA) VIA THE COMBINED TECHNIQUE USING THE PHENOM¿ 21 MICROCATHETER (MEDTRONIC), A 6.5MM X 45MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309645 / 24A112AV), AND A CEREGLIDE 71 INTERMEDIATE CATHETER (CATALOG / LOT# UNKNOWN), THE DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). IT WAS REPORTED THAT AFTER THE THROMBUS WAS RETRIEVED VIA THE COMBINED TECHNIQUE AFTER ONE PASS, THE EMBOTRAP III WAS BEING PULLED OUT FROM THE CONCOMITANT PHENOM 21 MICROCATHETER, BUT IT COULD NOT BE PULLED OUT. A HOLE WAS FOUND IN THE PHENOM 21 MICROCATHETER AND THE OUTER CAGE OF THE EMBOTRAP III DEVICE WAS PROTRUDING THROUGH THIS HOLE. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 25-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT PHOTOS OF THE DEVICE ARE NOT AVAILABLE. ON 03-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE ADDITIONAL INFORMATION CONFIRMED THE EMBOTRAP III DEVICE WAS USED VIA THE COMBINED TECHNIQUE FOR ONLY ONE PASS AND RECANALIZATION WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131136 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/ LOT # UNKNOWN) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE LEFT INTERNAL CAROTID ARTERY (ICA). DURING THE PROCEDURE, THE USER REPORTED RECANALIZATION OF LEFT INTERNAL CAROTID ARTERY WAS ACHIEVED AFTER THE FIRST RETRIEVAL ATTEMPT, BUT EMBOLIZATION OCCURRED TO THE ANTERIOR CEREBRAL ARTERY (ACA). A SECOND AND THIRD PASS WAS MADE AT THE ACA SITE, BUT RECANALIZATION WAS NOT ACHIEVED. THE PROCEDURE WAS THEN TERMINATED ¿BECAUSE IT HAD BEEN ABOUT AN HOUR SINCE THE START OF THE PROCEDURE, AND THERE WERE INSURANCE RESTRICTIONS BECAUSE THREE DEVICES HAD BEEN USED.¿ THERE WERE NO CLINICAL SYMPTOMS TO THE PATIENT. CONTINUOUS FLUSH WAS UNKNOWN. OTHER CONCOMITANT DEVICES WERE UNKNOWN. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF LEFT INTERNAL CAROTID ARTERY OCCLUSION. 9FR BALLOON GUIDING CATHETER, 0.071-INCH AND 0.046-INCH ACCESS CATHETER, THE EMBOTRAP 6.5MMX45MM WERE USED FOR THE PROCEDURE. ANGIOGRAPHY AFTER 1 PASS SHOWED RECANALIZATION OF LEFT INTERNAL CAROTID ARTERY BUT EMBOLIZATION IN THE ACA. FOR THE 2ND AND 3RD PASS TO ACA, ASPIRATI

  Patient problems: Thromboembolism

  MAUDE report 20033513 ↗
• InjuryAug 22, 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 62-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A HISTORY OF DIABETES AND HYPERTENSION, PRESENTED WITH AN UNWITNESSED WAKE-UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2023 AT 04:00. SYMPTOMS WERE FIRST OBSERVED ON THE SAME DAY AT 05:00. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023 AT 06:46, WHERE MRI 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 ¿LARGE-ARTERY DISEASE (CERVICAL ATHEROSCLEROSIS).¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 11 AND MODIFIED RANKING SCALE SCORE MRS SCORE WAS ¿0-NO SYMPTOMS.¿ ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/23D024AV) AND AN EMBOVAC IC 71, 132 CM, CE, ASP. IND. (IC71132CA/31041010) FOR OCCLUSIONS AT THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS WAS DONE AT THE ICA SITE, WHICH RESULTED IN A MTICI SCORE OF 2A, WITH NO CLOT RETRIEVAL. THE 2ND PASS WAS DONE AT THE M2 SITE, WHICH RES

  Patient problems: Stroke/CVA

  MAUDE report 20032274 ↗
• DeathAug 6, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/ 24C158AV) AND AN UNKNOWN CEREGLIDE71 INTERMEDIATE CATHETER (PRODUCT CODE/LOT # UNKNOWN) WERE USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA), WHICH WAS A CARDIOGENIC CEREBRAL EMBOLISM. DURING THE PROCEDURE, THE USER REPORTED WITHDRAWAL DIFFICULTY OF THE EMBOTRAP III INTO THE INTERMEDIATE CATHETER. RECANALIZATION WAS ACHIEVED BY 2 PASSES. NO BLEEDING WAS OBSERVED ON POST-RETRIEVAL IMAGING; HOWEVER, POST-PROCEDURAL MRI IMAGING SHOWED A SMALL AMOUNT OF HEMORRHAGE NEAR BASAL GANGLIA. MEDICATION WAS PROVIDED FOR MANAGING BLOOD PRESSURE. THE NEXT DAY, MRI FOUND ENLARGEMENT OF HEMORRHAGE, AND THE PATIENT SUBSEQUENTLY DIED IN A FEW DAYS. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF LEFT MIDDLE CEREBRAL ARTERY M1 OCCLUSION FOR CARDIOGENIC CEREBRAL EMBOLISM. STENOSIS WAS OBSERVED PRIOR TO C3 CURVE. THE EMBOTRAP III AND RED72 WERE ATTEMPTED TO ADVANCE TO THE LESION, BUT THE RED72 COULD NOT BE ADVANCED, SO REPLACED WITH THE CEREGLIDE71. THE EMBOTRAP III WAS MANAGED TO ADVANCE NEAR C3 STENOSED

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19918524 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT A 132CM CEREGLIDE 71 CATHETER (NIC71132C/LOT # UNKNOWN) AND AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/LOT # UNKNOWN), WERE USED FOR A MECHANICAL THROMBECTOMY OF LEFT INTERNAL CAROTID ARTERY (ICA) OCCLUSION FOR ACUTE CEREBRAL INFARCTION. TWO PASSES WERE MADE BY USING EMBOTRAP ¿ AND THE CEREGLIDE 71, AND RECANALIZATION WAS ACHIEVED. HOWEVER, AT THIS TIME THE USER REPORTED A ¿FILLING DEFECT¿ WAS FOUND AT THE ANTERIOR CEREBRAL ARTERY. A DIRECT ASPIRATION, FIRST PASS TECHNIQUE (ADAPT) WAS PERFORMED BY USING VECTA46 INTERMEDIATE CATHETER (STRYKER) AND FULL RECANALIZATION WAS ACHIEVED. THE USER REPORTED EXTENSIVE ISCHEMIC FOCI WERE OBSERVED BECAUSE IT TOOK A LONG TIME FROM ONSET TO COMPLETION OF THE PROCEDURE. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF LEFT INTERNAL CAROTID ARTERY OCCLUSION FOR ACUTE CEREBRAL INFARCTION. 2 PASSES WERE MADE BY USING EMBOTRAP ¿ 6.5×45 AND THE CEREGLIDE 71, AND RECANALIZATION WAS ACHIEVED. FILLING DEFECT WAS FOUND AT ANTERIOR CEREBRAL ARTERY, SO ADAPT WAS PERFORMED BY USING VECTA46 AND FULL RECANALIZATION WAS ACHIEVED. THE FULLY RECANALIZATION WAS ACHIEVED 90 MINUTES AFTER

  Patient problems: Thromboembolism

  MAUDE report 19690974 ↗
• InjuryJun 18, 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 PATIENT OF UNKNOWN AGE, GENDER, OR MEDICAL HISTORY (SUBJECT (B)(6), PRESENTED WITH AN UNKNOWN STROKE TYPE ON AN UNKNOWN DATE. ON 02-JUN-2024, THE PATIENT EXPERIENCED THE ADVERSE EVENT OF ¿LARGE MCA TERRITORY INFARCT WITH INTRAPARENCHYMAL AND SUBARACHNOID HAEMORRHAGE,¿ WHICH BECAME KNOWN TO THE SITE AND SPONSOR ON 07-JUN-2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS NOT SERIOUS. THE SEVERITY AND RELATIONSHIP TO THE EMBOTRAP STUDY DEVICE, LARGE BORE CATHETER, CEREGLIDE71, AND SURGICAL PROCEDURE, WERE NOT MADE AVAILABLE. IT IS UNKNOWN IF THE EVENT WAS MEDICALLY/SURGICALLY TREATED. THE OUTCOME IS RECORDED AS ¿RECOVERING/RESOLVING¿ WITH NO END DATE LISTED. ADDITIONAL PATIENT AND PROCEDURAL INFORMATION WERE NOTED IN THE CLINICAL DATABASE, THE CRF AT THE TIME OF THIS REVIEW, 14-JUN-2024. SUMMARY: THE PATIENT IS A 75-YEAR-OLD MALE PATIENT, WITH A MEDICAL HISTORY OF HYPERTENSION. THE PATIENT PRESENTED WITH A WITNESSED STROKE ON 01-JUN-2024 AT 18:30. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON 01-JUN-2024 AT 22:17, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTER

  Patient problems: Intracranial Hemorrhage; Swelling/ Edema

  MAUDE report 19557584 ↗
• MalfunctionJun 5, 2024Entrapment of Device; Fracture; Retraction Problem; Entrapment of Device; Fracture; Retraction Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/ 23K106AV) WAS USED FOR A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE DISTAL M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE USER REPORTED WITHDRAWAL DIFFICULTY OF THE EMBOTRAP INTO THE GUIDEWIRE/INTERMEDIATE CATHETER, DEVICE ENTANGLEMENT WITH ANOTHER DEVICE (SYNCHRO GUIDEWIRE; STRYKER), AND EMBOTRAP FRACTURE DURING WITHDRAWAL FROM VESSEL. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF RIGHT MIDDLE CEREBRAL ARTERY M1 DISTAL OCCLUSION FOR CEREBRAL INFARCTION. DURING SYNCHRO GUIDEWIRE INSERTION, THE WIRE WAS IN J SHAPED AND FORCIBLY PUSHED FORWARD, AND TRAK MICROCATHETER WAS ALSO QUITE DIFFICULT TO ADVANCE. 1 PASS WAS PERFORMED BY USING TREVO, BUT THE THROMBUS COULD NOT BE RETRIEVED, AND THE SECOND PASS WAS ALSO PERFORMED BY TREVO. WHEN ATTEMPTING THE THIRD PASS, ADVANCED THE SYNCHRO AND THE TRAK, THE SYNCHRO GOT BROKEN AROUND M1D TO SIPHON AREA, AND THE SEPARATED TIP OF THE SYNCHRO WAS TRAPPED AT LSA [LENTICULOSTRIATE ARTERY]. ATTEMPTED TO RETRIEVE THE SEPARATED SYNCHRO TIP USING A TREVO, BUT WERE UNABLE TO RETRIEVE IT, S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469121 ↗
• MalfunctionApr 29, 2024Fracture; Retraction Problem; Fracture; Retraction Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/ 24B092AV) WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED STRUT SEPARATION OF THE EMBOTRAP III DEVICE WHILE IN PATIENT. THE FRAGMENT WAS CAPTURED WITHIN AND RETRIEVED THROUGH THE BASE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO INJURY TO THE PATIENT. THE EVENT RESULTED IN A FIVE-MINUTE DELAY, DURING WHICH THE DEVICE AND FRAGMENT WAS BEING REMOVED FROM THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THE EVENT WAS REPORTED AS SUCH, ¿DISTAL TIP OF EMBOTRAP III 6.5 X 45 FRACTURED OFF IN PATIENT. FRAGMENT WAS CAPTURED WITHIN AND RETRIEVED THROUGH BASE CATHETER. NO INJURY TO PATIENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? ¿YES.¿ IF YES, NUMBER OF MINUTES: ¿5.¿ ACTION TAKEN WHEN EVENT OCCURRED? ¿DEVICE REMOVED. FRAGMENTS RETRIEVED.¿ WAS PROCEDURE SUCCESSFULLY COMPLETED? ¿YES.¿ WERE FRAGMENTS GENERATED? ¿YES.¿ IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? ¿YES.¿ PATIENT STATUS/ OUTCOME / CONSEQUENCES? ¿NO.¿ WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: ¿N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201848 ↗
• MalfunctionMar 19, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, THIS WAS A MECHANICAL THROMBECTOMY OF SINUS VENOSUS THROMBOSIS. THE PROCEDURE WAS PERFORMED BY COMBINED TECHNIQUE. AFTER A PHENOM¿ 27 MICROCATHETER (MEDTRONIC) WAS ADVANCED TO THE LESION, AN ATTEMPT WAS MADE TO INSERT AN EMBOTRAP III 6.5 MM X 45 MM THROMBUS RETRIEVER (ET309645, 23J079AV), BUT COULD NOT BECAUSE IT BECAME STUCK AT THE MIDDLE AND DID NOT PASS THE PHENOM21. THE PHENOM21 WAS REPLACED WITH ANOTHER PHENOM27 MICROCATHETER (MC) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 08-MAR-2024 INDICATING THAT NEITHER THE MICROCATHETER NOR THE EMBOTRAP APPEAR DAMAGED. THE INSERTION TOOL WAS SECURELY PLACED IN THE HUB OF THE MICROCATHETER PRIOR TO ATTEMPTING TO ADVANCE THE EMBOTRAP. THERE WAS FLUSHING DIFFICULTIES. THE DEVICE WAS ABLE TO ADVANCE THROUGH THE HUB. THERE WAS NO KINK IN THE MC. THE SAME EMBOTRAP WAS ADVANCED THROUGH THE NEW MICROCATHETER. ONE PASS WAS MADE TO ATTEMPT TO RETRIEVE THE CLOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932012 ↗
• InjuryMar 12, 2024Entrapment of Device; Fracture; Retraction Problem; Entrapment of Device; Fracture; Retraction Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 6.5 MM X 45 MM (ET309645/ 23J079AV) AND AN UNKNOWN EMBOGUARD BALLOON GUIDE CATHETER (BG8795U/LOT # UNKNOWN) WERE USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE ¿INTERNAL CAROTID ARTERY (ICA) TO M1.¿ DURING THE PROCEDURE, THE USER REPORTED EMBOGUARD-TRACKING DIFFICULTY, AND EMBOTRAP-WITHDRAWAL DIFFICULTY INTO GUIDE/INTERMEDIATE CATHETER (UNABLE TO), DEVICE ENTANGLEMENT WITH OTHER DEVICE (EG STENT), AND STRUT SEPARATION. THE EVENT WAS REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF INTERNAL CAROTID ARTERY (ICA) TO M1 OCCLUSION. THE ICA WAS SEVERELY TORTUOUS, AND A PRECISE STENT HAD BEEN IMPLANTED TO THE ICA PREVIOUSLY. THE EMBOGUARD WAS INSERTED TO THE PATIENT BODY AND ATTEMPTED TO BE DELIVERED BEYOND THE PRECISE STENT, BUT THE EMBOGUARD COULD NOT PASS THROUGH THE STENT BECAUSE THE LOCATION OF THE ICA WAS TOO NARROW. THE LOCATION OF THE THROMBUS WAS CONFIRMED AT ICA TO M1. A MECHANICAL THROMBECTOMY WAS PERFORMED BY USING EMBOTRAP III AND A SOFIA ASPIRATION CATHETER. AFTER THE EMBOTRAP III WAS DEPLOYED, THE STENT LIKE ASSEMBLY OF THE EMBOTRAP III WITH THE THROMBUS WAS ATTEMPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886764 ↗