BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOTRAP II 5X33 REVASC. DEV.

    MDR report key: 7808472 · Received August 23, 2018

    Report

    Report Number
    3011370111-2018-00102
    Event Type
    Injury
    Date Received
    August 23, 2018
    Date of Event
    August 3, 2018
    Report Date
    August 6, 2018
    Manufacturer
    NEURAVI LIMITED
    Product Code
    NRY
    UDI-DI
    10886704081326
    PMA / PMN Number
    K173452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). MANUFACTURER POSTAL CODE: H91 PV0V. [COMPLAINT CONCLUSION] AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A THROMBECTOMY OF AN OCCLUSION IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), THE 89-YEAR-OLD PATIENT DEVELOPED A CAROTID-CAVERNOUS FISTULA (CCF) AFTER WITHDRAWING THE 5X33 EMBOTRAP II (ET009533/18E118AV) REVASCULARIZATION DEVICE. AS THE PHYSICIAN WAS RETRIEVING THE EMBOTRAP II DEVICE, HE ENCOUNTERED LITTLE (NOT EXCESSIVE) RESISTANCE WHILE PASSING THROUGH THE SUPRACLINOID SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE EMBOTRAP II DEVICE APPEARED TO HAVE CAPTURED MINIMAL STRINGY CLOT IN ONE PASS. ANGIOGRAPHIC RUN PERFORMED IMMEDIATELY AFTER REVEALED A CCF. THE PHYSICIAN USED A SOFIA 125CM DISTAL ACCESS CATHETER AND A COMPETITOR REVASCULARIZATION DEVICE TO RETRIEVE THE CLOT. ANGIOGRAPHIC RUN WAS REPEATED AND THE CCF HAD RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. NO VISIBLE DAMAGE WAS NOTED TO THE EMBOTRAP II PRIOR TO INSERTION. CONCOMITANT DEVICES USED IN THE CASE INCLUDED A MERCI 8F BALLOON GUIDE CATHETER, SYNCHRO SOFT .014 200CM GUIDEWIRE, AND A PROWLER SELECT PLUS MICROCATHETER. THE TREATING PHYSICIAN DOES NOT BELIEVE THAT THE DEVICES USED IN THE CASE CONTRIBUTED TO THE EVENT. THE PHYSICIAN STATED THAT SOMETIMES HE REMOVES THE MICROCATHETER FULLY DURING RETRIEVAL BUT DOES NOT RECALL IF HE DID IN THIS CASE. IT WAS LAST REPORTED THAT THE PATIENT DID NOT DO WELL, BUT IT WAS NOT BECAUSE OF A TECHNICAL ISSUE; THERE WERE OTHER FACTORS INVOLVED. MULTIPLE ATTEMPTS TO OBTAIN CASE IMAGING WERE UNSUCCESSFUL. NO FURTHER INFORMATION WAS PROVIDED. THE EMBOTRAP II DEVICE WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. VASCULAR INJURY OR PERFORATION ARE KNOWN POTENTIAL COMPLICATIONS THAT CAN OCCUR WITH THE USE OF THE EMBOTRAP AND WITH ANY PROCEDURES INVOLVING MANIPULATION OF DEVICES WITHIN THE CEREBRAL VASCULATURE. 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, CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION, VESSEL CHARACTERISTICS, AND DEVICE SELECTION, MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE FISTULA. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. IMAGING IS AVAILABLE FOR REVIEW, BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT MED PRODUCTS DUE TO CHARACTER LIMITATION: MERCI 8F 95CM BALLOON GUIDE CATHETER, SYNCHRO SOFT .014 200CM GUIDEWIRE, PROWLER SELECT PLUS MICROCATHETER, SOLITAIRE 4MM X 40MM MECHANICAL THROMBECTOMY DEVICE, SOFIA 125CM ASPIRATION CATHETER. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A THROMBECTOMY OF AN OCCLUSION IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), THE (B)(6) -YEAR-OLD PATIENT DEVELOPED A CAROTID-CAVERNOUS FISTULA (CCF) AFTER WITHDRAWING THE 5X33 EMBOTRAP II (ET009533/18E118AV) REVASCULARIZATION DEVICE. AS THE PHYSICIAN WAS RETRIEVING THE EMBOTRAP II DEVICE, HE ENCOUNTERED LITTLE (NOT EXCESSIVE) RESISTANCE WHILE PASSING THROUGH THE SUPRACLINOID SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE EMBOTRAP II DEVICE APPEARED TO HAVE CAPTURED MINIMAL STRINGY CLOT IN ONE PASS. ANGIOGRAPHIC RUN PERFORMED IMMEDIATELY AFTER REVEALED A CCF. THE PHYSICIAN USED A SOFIA 125CM DISTAL ACCESS CATHETER AND A COMPETITOR REVASCULARIZATION DEVICE TO RETRIEVE THE CLOT. ANGIOGRAPHIC RUN WAS REPEATED AND THE CCF HAD RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. NO VISIBLE DAMAGE WAS NOTED TO THE EMBOTRAP II PRIOR TO INSERTION. CONCOMITANT DEVICES USED IN THE CASE INCLUDED A MERCI 8F BALLOON GUIDE CATHETER, SYNCHRO SOFT .014 200CM GUIDEWIRE, AND A PROWLER SELECT PLUS MICROCATHETER. THE TREATING PHYSICIAN DOES NOT BELIEVE THAT THE DEVICES USED IN THE CASE CONTRIBUTED TO THE EVENT. THE PHYSICIAN STATED THAT SOMETIMES HE REMOVES THE MICROCATHETER FULLY DURING RETRIEVAL BUT DOES NOT RECALL IF HE DID IN THIS CASE. IT WAS LAST REPORTED THAT THE PATIENT DID NOT DO WELL, BUT IT WAS NOT BECAUSE OF A TECHNICAL ISSUE; THERE WERE OTHER FACTORS INVOLVED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. IMAGING IS AVAILABLE FOR REVIEW, BUT HAS NOT YET BEEN RECEIVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650106 EMBOTRAP II 5X33 REVASC. DEV. CATHETER, THROMBUS RETRIEVER NRY NEURAVI LIMITED 18E118AV 10886704081326

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Life Threatening