BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOTRAP II 5X33 REVASC. DEV.

    MDR report key: 12160322 · Received July 13, 2021

    Report

    Report Number
    3011370111-2021-00054
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    June 24, 2021
    Report Date
    June 23, 2021
    Manufacturer
    NEURAVI LTD.
    Product Code
    NRY
    UDI-DI
    10886704081326
    PMA / PMN Number
    K173452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED DATA: SECTION B3. DATE OF EVENT: (B)(6) 2021.

    Additional Manufacturer Narrative · 0

    (B)(4) INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: A REPORT FROM THE FIELD INDICATED THAT DURING AN ENDOVASCULAR MECHANICAL THROMBECTOMY OF A MIDDLE CEREBRAL ARTERY (MCA) (M2 ORIGIN) OCCLUSION IN A (B)(6)-YEAR-OLD MALE, A SLIGHT SUBARACHNOID HEMORRHAGE (SAH) WAS NOTED AT THE TIME OF THROMBUS REMOVAL. IT WAS REPORTED THAT THE 5MM X 3MM EMBOTRAP II (ET009533/21B021AV) REVASCULARIZATION DEVICE AND 132CM EMBOVAC 71 (IC71132CA/30541397) ASPIRATION CATHETER WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PROXIMAL MARKER OF THE EMBOTRAP II AND PROXIMAL THROMBUS WERE ¿FIT¿ AND THE EMBOTRAP II WAS DEPLOYED. NEXT, THE EMBOVAC ASPIRATION CATHETER WAS DELIVERED TO THE DISTAL M1 SEGMENT OF THE MCA AS THE EMBOTRAP II WAS USED AS AN ANCHORING DEVICE. HALF OF THE EMBOTRAP II WAS CONTAINED IN THE EMBOVAC CATHETER AND RETRACTED. COMPLETE PERFUSION (MTICI SCORE OF 3) WAS ACHIEVED DURING THE FIRST PASS. HOWEVER, SLIGHT SAH WAS OBSERVED VIA IMAGING. THE PATIENT REMAINS HOSPITALIZED AND HAS BEEN ¿DRAMATICALLY¿ RECOVERING FROM THE SAH. THE PHYSICIAN IS NOT GOING TO PROVIDE ANY ADDITIONAL TREATMENT FOR THE PATIENT. HE WILL BE DISCHARGED BACK HOME. IN THE PHYSICIAN¿S OPINION, THE EVENT WAS NOT SERIOUS. THE PHYSICIAN FURTHER COMMENTED THAT IT IS UNCLEAR WHAT CAUSED THE SAH; HOWEVER, THE RELATIONSHIP OF THE COMPLAINT DEVICES TO THE BLEED CANNOT BE EXCLUDED. POTENTIAL CONTRIBUTING FACTORS INCLUDE ¿WIRING OPERATION¿ AND ¿STRESS¿ DURING DEVICE RETRACTED. ADDITIONAL INFORMATION RECEIVED ON 05 JUL 2021 INDICATED THAT THE SAH WAS SEEN AT THE DISTAL M2 SEGMENT OF THE MCA. IT WAS NOT OBSERVED IMMEDIATELY AFTER THE OPERATION BUT WAS FOUND ON COMPUTED TOMOGRAPHY (CT) IMAGING ON THE FOLLOWING DAY. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE SAH. NO MEDICAL INTERVENTION (I.E., DRUG ADMINISTRATION) WAS PERFORMED. THE EVENT DID NOT REQUIRE PROLONGATION OF EXISTING HOSPITALIZATION. THE PHYSICIAN COMMENTED THAT THERE IS NO CAUSAL RELATIONSHIP WITH THE EMBOVAC CATHETER BUT THE EMBOTRAP II HAD A CAUSAL RELATIONSHIP WITH THE SAH. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 12 JUL 2021 INDICATED THAT THE PATIENT RECOVERED AND WILL BE DISCHARGED FROM THE HOSPITAL WITHOUT ANY PROGNOSTIC SYMPTOMS. THE EMBOTRAP DEVICE WAS DEPLOYED BETWEEN THE M2 AND M1 BY ALIGNING THE PROXIMAL MARKERS WITH THE PROXIMAL END OF THE CLOT. THE EMBOVAC CATHETER WAS DELIVERED TO THE M1 BY ANCHORING THE EMBOTRAP DEVICE POST-DEPLOYMENT. THERE WERE NO ALLEGED DEVICE MALFUNCTIONS ASSOCIATED WITH THE EMBOTRAP OR EMBOVAC. THERE WAS NO REPORT OF RESISTANCE WHEN CROSSING THE CLOT OR DURING WITHDRAWAL. THERE WAS NO UNINTENDED MOVEMENT DURING THE PROCEDURE. THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE EMBOTRAP AND EMBOVAC: CHIKAI (ASAHI INTECC) GUIDEWIRE, 9F OPTIMO (TOKAI) BALLOON GUIDE CATHETER, AND TRACK 21 (STRYKER) MICROCATHETER. IT IS NOT KNOWN IF THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. IT IS ALSO UNKNOWN WHETHER THE EMBOTRAP DEVICE INTERACTED WITH THE LOCATION OF THE SAH (DISTAL M2). ANONYMIZED IMAGES/ANGIOGRAPHS OF THE PROCEDURE HAVE NOT BEEN PROVIDED. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 21B021AV PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. VESSEL INJURY AND HEMORRHAGE ARE KNOWN POTENTIAL PROCEDURAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE EMBOTRAP II REVASCULARIZATION DEVICE. WITH THE AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, THE EVENT MAY HAVE BEEN RELATED TO A COMBINATION OF MULTIPLE FACTORS EXPERIENCED IN THE CLINICAL SETTING RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. BASED ON THE PHYSICIAN REPORT THAT THE RELATIONSHIP OF THE EMBOTRAP II TO THE VESSEL TRAUMA WITH CONSEQUENT SAH CANNOT BE EXCLUDED. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    A REPORT FROM THE FIELD INDICATED THAT DURING AN ENDOVASCULAR MECHANICAL THROMBECTOMY OF A MIDDLE CEREBRAL ARTERY (MCA) (M2 ORIGIN) OCCLUSION IN A (B)(6) YEAR-OLD MALE, A SLIGHT SUBARACHNOID HEMORRHAGE (SAH) WAS NOTED AT THE TIME OF THROMBUS REMOVAL. IT WAS REPORTED THAT THE 5MM X 3MM EMBOTRAP II (ET009533/21B021AV) REVASCULARIZATION DEVICE AND 132CM EMBOVAC 71 (IC71132CA/30541397) ASPIRATION CATHETER WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PROXIMAL MARKER OF THE EMBOTRAP II AND PROXIMAL THROMBUS WERE ¿FIT¿ AND THE EMBOTRAP II WAS DEPLOYED. NEXT, THE EMBOVAC ASPIRATION CATHETER WAS DELIVERED TO THE DISTAL M1 SEGMENT OF THE MCA AS THE EMBOTRAP II WAS USED AS AN ANCHORING DEVICE. HALF OF THE EMBOTRAP II WAS CONTAINED IN THE EMBOVAC CATHETER AND RETRACTED. COMPLETE PERFUSION (MTICI SCORE OF 3) WAS ACHIEVED DURING THE FIRST PASS. HOWEVER, SLIGHT SAH WAS OBSERVED VIA IMAGING. THE PATIENT REMAINS HOSPITALIZED AND HAS BEEN ¿DRAMATICALLY¿ RECOVERING FROM THE SAH. THE PHYSICIAN IS NOT GOING TO PROVIDE ANY ADDITIONAL TREATMENT FOR THE PATIENT. HE WILL BE DISCHARGED BACK HOME. IN THE PHYSICIAN¿S OPINION, THE EVENT WAS NOT SERIOUS. THE PHYSICIAN FURTHER COMMENTED THAT IT IS UNCLEAR WHAT CAUSED THE SAH; HOWEVER, THE RELATIONSHIP OF THE COMPLAINT DEVICES TO THE BLEED CANNOT BE EXCLUDED. POTENTIAL CONTRIBUTING FACTORS INCLUDE ¿WIRING OPERATION¿ AND ¿STRESS¿ DURING DEVICE RETRACTED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 05 JUL 2021 INDICATED THAT THE SAH WAS SEEN AT THE DISTAL M2 SEGMENT OF THE MCA. IT WAS NOT OBSERVED IMMEDIATELY AFTER THE OPERATION BUT WAS FOUND ON COMPUTED TOMOGRAPHY (CT) IMAGING ON THE FOLLOWING DAY. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE SAH. NO MEDICAL INTERVENTION (I.E., DRUG ADMINISTRATION) WAS PERFORMED. THE EVENT DID NOT REQUIRE PROLONGATION OF EXISTING HOSPITALIZATION. THE PHYSICIAN COMMENTED THAT THERE IS NO CAUSAL RELATIONSHIP WITH THE EMBOVAC CATHETER BUT THE EMBOTRAP II HAD A CAUSAL RELATIONSHIP WITH THE SAH. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 12 JUL 2021 INDICATED THAT THE PATIENT RECOVERED AND WILL BE DISCHARGED FROM THE HOSPITAL WITHOUT ANY PROGNOSTIC SYMPTOMS. THE EMBOTRAP DEVICE WAS DEPLOYED BETWEEN THE M2 AND M1 BY ALIGNING THE PROXIMAL MARKERS WITH THE PROXIMAL END OF THE CLOT. THE EMBOVAC CATHETER WAS DELIVERED TO THE M1 BY ANCHORING THE EMBOTRAP DEVICE POST-DEPLOYMENT. THERE WERE NO ALLEGED DEVICE MALFUNCTIONS ASSOCIATED WITH THE EMBOTRAP OR EMBOVAC. THERE WAS NO REPORT OF RESISTANCE WHEN CROSSING THE CLOT OR DURING WITHDRAWAL. THERE WAS NO UNINTENDED MOVEMENT DURING THE PROCEDURE. THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE EMBOTRAP AND EMBOVAC: CHIKAI (ASAHI INTECC) GUIDEWIRE, 9F OPTIMO (TOKAI) BALLOON GUIDE CATHETER, AND TRACK 21 (STRYKER) MICROCATHETER. IT IS NOT KNOWN IF THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. IT IS ALSO UNKNOWN WHETHER THE EMBOTRAP DEVICE INTERACTED WITH THE LOCATION OF THE SAH (DISTAL M2). ANONYMIZED IMAGES/ANGIOGRAPHS OF THE PROCEDURE HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053813 EMBOTRAP II 5X33 REVASC. DEV. CATHETER, THROMBUS RETRIEVER NRY NEURAVI LTD. ET009533 21B021AV 10886704081326

    Patients

    Seq Age Sex Outcome Treatment
    1 132CM EMBOVAC 71 ASP. CATHETER| 9FR OPTIMO GUIDING CATHETER| CHIKAI, ASAHI INTECC GUIDEWIRE| TRACK21, STRYKER MICROCATHETER