BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOTRAP III 5 MM X 22 MM

    MDR report key: 12188700 · Received July 19, 2021

    Report

    Report Number
    3011370111-2021-00058
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    April 9, 2021
    Report Date
    July 9, 2021
    Manufacturer
    NEURAVI LTD.
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION B5: ADDITIONAL EVENT INFORMATION RECEIVED ON 23-AUG-2021 INDICATED THAT THE LOT NUMBER OF THE EMBOTRAP III WAS 21A037AV AND THE LOT NUMBER OF THE EMBOVAC WAS 30438901. THE PHYSICIAN DOES NOT FEEL THAT THE EMBOVAC CATHETER HAD ANY INVOLVEMENT OR RELATIONSHIP WITH THE SAB. THE PROCEDURE WAS TERMINATED AFTER THIS COMPLICATION OCCURRED. THE PHYSICIAN MONITORED THE PATIENT FOR A FEW MINUTES AFTER LOWERING THE BLOOD PRESSURE (RR) UNDER 120 MM HG AND DID ANOTHER ANGIO RUN. THE BLEEDING STOPPED SPONTANEOUSLY, SINCE THE M2 BRANCH WAS LEFT OCCLUDED. ANONYMIZED PROCEDURAL IMAGING/FILMS WERE RECEIVED. THE RETURNED IMAGES WERE REVIEWED BY AN INDEPENDENT MEDICAL AFFAIRS CONSULTANT, NEUROVASCULAR SURGEON, THE ASSESSMENT READS AS FOLLOWS: "A COMPLAINT OF SUBARACHNOID HEMORRHAGE AFTER DEPLOYMENT OF A 5MM EMBOTRAP III IN THE M2 IS MADE. THE COMPLAINT IS ACCOMPANIED BY 7 LATERAL IMAGES FROM A RT MCA THROMBECTOMY PROCEDURE AND A SINGLE AXIAL CT HEAD IMAGE. IMAGING DEMONSTRATES AN EMBOTRAP IN A RIGHT MCA M2 SEGMENT. THERE IS NO SIGNIFICANT TORTUOSITY OF THE VESSELS. THE SUBSEQUENT IMAGES DEMONSTRATE A PERSISTENT OCCLUSION OF THE DISTAL RIGHT MCA M2 SEGMENT. THE LATER ANGIOGRAM IMAGES DEMONSTRATE A SMALL AMOUNT OF CONTRAST EXTRAVASATION IN THE RIGHT SYLVIAN FISSURE. THIS IS CONFIRMED ON THE AXIAL CT HEAD ¿ A SMALL AMOUNT OF SUBARACHNOID HEMORRHAGE WITHOUT MASS AFFECT. THE PATIENTS NIHSS IMPROVED FROM AN 18-7. COMPLAINT CONCLUSION: A REPORT FROM THE FIELD INDICATED THAT THE PATIENT SUFFERED FROM A SUBARACHNOID BLEED (SAB) AFTER USE OF A 5MM X 22MM EMBOTRAP III (ET307522/21A037AV) REVASCULARIZATION DEVICE. THE PATIENT INITIALLY PRESENTED WITH A MIDDLE CEREBRAL ARTERY (M1 SEGMENT) OCCLUSION. THE FIRST PASS MADE WITH AN EMBOVAC (UNKNOWN PRODUCT CODE/30438901) ASPIRATION CATHETER AND THE EMBOTRAP III RESULTED IN REOPENING OF THE M1 SEGMENT OCCLUSION. A SECOND PASS WAS REQUIRED AT THE M2 SEGMENT, SO THE PHYSICIAN USED THE SAME EMBOTRAP III. IMMEDIATELY AFTER USE OF THE EMBOTRAP III, HE OBSERVED CONTRAST GOING OUT OF THE VESSEL. COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THE SAB. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT¿S NIHSS SCORE IMPROVED FROM 18 (BASELINE) TO 7. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-AUG-2021 INDICATED THAT THE PHYSICIAN DOES NOT FEEL THAT THE EMBOVAC CATHETER HAD ANY INVOLVEMENT OR RELATIONSHIP WITH THE SAB. THE PROCEDURE WAS TERMINATED AFTER THIS COMPLICATION OCCURRED. THE PHYSICIAN MONITORED THE PATIENT FOR A FEW MINUTES AFTER LOWERING THE BLOOD PRESSURE (RR) UNDER 120 MM HG AND DID ANOTHER ANGIO RUN. THE BLEEDING STOPPED SPONTANEOUSLY, SINCE THE M2 BRANCH WAS LEFT OCCLUDED. ANONYMIZED PROCEDURAL IMAGING/FILMS WERE RECEIVED. THE RETURNED IMAGES WERE REVIEWED BY AN INDEPENDENT MEDICAL AFFAIRS CONSULTANT, NEUROVASCULAR SURGEON, THE ASSESSMENT READS AS FOLLOWS: "A COMPLAINT OF SUBARACHNOID HEMORRHAGE AFTER DEPLOYMENT OF A 5MM EMBOTRAP III IN THE M2 IS MADE. THE COMPLAINT IS ACCOMPANIED BY 7 LATERAL IMAGES FROM A RT MCA THROMBECTOMY PROCEDURE AND A SINGLE AXIAL CT HEAD IMAGE. IMAGING DEMONSTRATES AN EMBOTRAP IN A RIGHT MCA M2 SEGMENT. THERE IS NO SIGNIFICANT TORTUOSITY OF THE VESSELS. THE SUBSEQUENT IMAGES DEMONSTRATE A PERSISTENT OCCLUSION OF THE DISTAL RIGHT MCA M2 SEGMENT. THE LATER ANGIOGRAM IMAGES DEMONSTRATE A SMALL AMOUNT OF CONTRAST EXTRAVASATION IN THE RIGHT SYLVIAN FISSURE. THIS IS CONFIRMED ON THE AXIAL CT HEAD ¿ A SMALL AMOUNT OF SUBARACHNOID HEMORRHAGE WITHOUT MASS AFFECT. THE PATIENTS NIHSS IMPROVED FROM AN 18-7. THE EMBOTRAP WAS NOT RETURNED FOR ANALYSIS, THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A DEVICE HISTORY REVIEW ASSOCIATED WITH LOT NUMBER 21A037AV PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. SUBARACHNOID HEMORRHAGE IS A KNOWN COMPLICATION FOLLOWING THROMBECTOMY. THIS CAN OCCUR FROM THE ASPIRATION CATHETER OR WIRE CAUSING A PERFORATION OF THE VESSEL. IT IS ALSO SEEN FOLLOWING THE USE OF A STENT RETRIEVER. THE MECHANISM IS LIKELY TEARING OF SMALL PERFORATOR VESSELS WHILE WITHDRAWING THE STENT RETRIEVER WHICH DISPLACES THE VESSELS OR MAY CAUSE A DISSECTION OF THE VESSEL." HEMORRHAGE SECONDARY TO VESSEL TRAUMA OR INJURY IS A WELL-KNOWN EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION ASSOCIATED WITH THE EMBOTRAP III REVASCULARIZATION DEVICE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. 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, THERE ARE CLINICAL AND PROCEDURAL FACTORS SUCH AS VESSEL CHARACTERISTICS, CLOT BURDEN/CHARACTERISTICS, DEVICE SELECTION, DEVICE INTERACTION, AND MECHANICAL MANIPULATION OF DEVICES WITHIN THE ARTERY THAT MAY HAVE CONTRIBUTED. THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED OR THAT IT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. 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 EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT THE PATIENT SUFFERED FROM A SUBARACHNOID BLEED (SAB) AFTER USE OF A 5MM X 22MM EMBOTRAP III (ET307522/UNKNOWN LOT NUMBER) REVASCULARIZATION DEVICE. THE PATIENT INITIALLY PRESENTED WITH A MIDDLE CEREBRAL ARTERY (M1 SEGMENT) OCCLUSION. THE FIRST PASS MADE WITH AN EMBOVAC (UNKNOWN PRODUCT CODE & LOT NUMBER) ASPIRATION CATHETER AND THE EMBOTRAP III RESULTED IN REOPENING OF THE M1 SEGMENT OCCLUSION. A SECOND PASS WAS REQUIRED AT THE M2 SEGMENT, SO THE PHYSICIAN USED THE SAME EMBOTRAP III. IMMEDIATELY AFTER USE OF THE EMBOTRAP III, HE OBSERVED CONTRAST GOING OUT OF THE VESSEL. COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THE SAB. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT¿S NIHSS SCORE IMPROVED FROM 18 (BASELINE) TO 7. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085698 EMBOTRAP III 5 MM X 22 MM CATHETER, THROMBUS RETRIEVER NRY NEURAVI LTD. 21A037AV

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN_EMBOVAC| UNKNOWN_EMBOVAC