BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOTRAP II 5X33 REVASC. DEV.

    MDR report key: 15361257 · Received September 6, 2022

    Report

    Report Number
    3011370111-2022-00083
    Event Type
    Death
    Date Received
    September 6, 2022
    Date of Event
    November 11, 2020
    Report Date
    September 6, 2022
    Manufacturer
    NEURAVI LTD.
    Product Code
    NRY
    UDI-DI
    10886704081326
    PMA / PMN Number
    K173452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, AND THE RACE WAS NOT REPORTED. PATIENT IDENTIFIER: (B)(6). MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: 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 30-OCT-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 RETRIEVER (STRYKER) AT THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), RESULTING IN AN MTICI SCORE OF 2A WITH CLOT RETRIEVAL IN THE STENT RETRIEVER. THE PREVIOUS DEVICE WAS CHANGED DUE TO VESSEL SIZE. ALL PASSES WERE MADE VIA A 0.027 AND 0.028 MARKSMAN MICROCATHETER (MEDTRONIC). A 0.027 MARKSMAN160 INTERMEDIATE CATHETER (MEDTRONIC) WAS USED DURING THE FIRST AND SECOND PASSES AND A 0.058 AXS CATALYST INTERMEDIATE CATHETER (STRYKER) WAS USED DURING THE THIRD, FOURTH, AND FIFTH PASSES. ALSO, A 0.038 TERUMO LONG SHEATH WAS USED DURING THE FOURTH PASS. NO FURTHER PASSES WERE MADE. ON (B)(6) 2020 THE PATIENT EXPIRED DUE TO UNKNOWN CAUSES. PER THE PRINCIPAL INVESTIGATOR (PI) THIS EVENT WAS ASSESSED AS SEVERE IN SEVERITY, SERIOUS (FATAL), AND NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 19-AUG-2022 INDICATING THAT THE RELATIONSHIP OF THE REPORTED DEATH TO THE STUDY DEVICE AND STUDY PROCEDURE WAS UPDATED FROM NOT RELATED TO POSSIBLE. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A REVIEW OF THE DHR RECORDS CONFIRMS THAT THERE WERE NO ISSUES WITH THE ASSEMBLY OF THE LOTS (SUB-ASSEMBLY AND TOP ASSEMBLY), ALL REJECTS WERE ACCOUNTED FOR DURING THE DHR REVIEW. DEATH IS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF THE EMBOTRAP II REVASCULARIZATION DEVICE AND IS MENTIONED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. ACCORDING TO THE INFORMATION PROVIDED, THE DEVICE PERFORMED AS INTENDED, AND NO NEW PATIENT CONSEQUENCES HAVE OCCURRED RELATED TO THE USE OF THE DEVICE. HOWEVER, PER THE ADDITIONAL INFORMATION RECEIVED ON 19-AUG-2022, THE PRINCIPAL INVESTIGATOR ASSESSED THE DEATH AS POSSIBLY RELATED TO THE STUDY DEVICE AND THE PRIMARY STUDY PROCEDURE. THEREFORE, THIS EVENT DOES MEET MDR REPORTING CRITERIA WITH AN AWARENESS DATE OF 19-AUG-2022. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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.

    Description of Event or Problem · 0

    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 RETRIEVER (STRYKER) AT THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), RESULTING IN AN MTICI SCORE OF 2A WITH CLOT RETRIEVAL IN THE STENT RETRIEVER. THE PREVIOUS DEVICE WAS CHANGED DUE TO VESSEL SIZE. ALL PASSES WERE MADE VIA A 0.027 AND 0.028 MARKSMAN MICROCATHETER (MEDTRONIC). A 0.027 MARKSMAN160 INTERMEDIATE CATHETER (MEDTRONIC) WAS USED DURING THE FIRST AND SECOND PASSES AND A 0.058 AXS CATALYST INTERMEDIATE CATHETER (STRYKER) WAS USED DURING THE THIRD, FOURTH, AND FIFTH PASSES. ALSO, A 0.038 TERUMO LONG SHEATH WAS USED DURING THE FOURTH PASS. NO FURTHER PASSES WERE MADE. ON (B)(6) 2020 THE PATIENT EXPIRED DUE TO UNKNOWN CAUSES. PER THE PRINCIPAL INVESTIGATOR (PI) THIS EVENT WAS ASSESSED AS SEVERE IN SEVERITY, SERIOUS (FATAL), AND NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 19-AUG-2022 INDICATING THAT THE RELATIONSHIP OF THE REPORTED DEATH TO THE STUDY DEVICE AND STUDY PROCEDURE WAS UPDATED FROM NOT RELATED TO POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561636 EMBOTRAP II 5X33 REVASC. DEV. CATHETER, THROMBUS RETRIEVER NRY NEURAVI LTD. ET009533 20D088AV 10886704081326

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death 0.027 MARKSMAN160 INTERMEDIATE CATHETER| 0.038 TERUMO LONG SHEATH| 0.058 AXS CATALYST INTERMEDIATE CATHETER (STRYKER)| 4MM X 30MM TREVO STENT RETRIEVER (STRYKER)| CEREBASE GUIDE CATHETER