BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_THROMBECTOMY NEURAVI

    MDR report key: 19435805 · Received May 31, 2024

    Report

    Report Number
    3011370111-2024-00043
    Event Type
    Death
    Date Received
    May 31, 2024
    Date of Event
    September 6, 2022
    Report Date
    May 31, 2024
    Manufacturer
    NEURAVI LTD.
    Product Code
    NRY
    PMA / PMN Number
    K173452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D.4: THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. CLINICIAN ASSESSMENT FOR PATIENT # 6 (77/F): SINCE THE EVENT OF SUBARACHNOID HEMORRHAGE RESULTING IN DEATH, CANNOT BE DISASSOCIATED FROM THE USED EMBOTRAP DEVICE, THE EVENT IS REPORTABLE TO THE US FDA UNDER THE CLASSIFICATION OF "DEATH." REGARDING THE USE OF THE INVOLVED GEOMETRIC CLOT EXTRACTOR (GCE) DEVICE; THE DEVICE HAS NOT BEEN APPROVED BY THE US FDA AND IS NOT MARKETED IN THE US. THEREFORE, THIS EVENT IS BEING REPORTED TO THE USFDA IN RELATION TO THE EMBOTRAP DEVICE. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: BORIESOSDICK J, MICHAEL AE, KRÖGER JR, NIEHOFF JH, SAEED S, PFLUG M, SCHELLINGER P, MAUS V, BORGGREFE J, MÖNNINGHOFF C. MECHANICAL THROMBECTOMY USING THE NIMBUS STENT-RETRIEVER - INITIAL EXPERIENCES IN A SINGLE-CENTER OBSERVATIONAL STUDY. INTERV NEURORADIOL. 2022 SEP 22:15910199221129097. DOI: 10.1177/15910199221129097. EPUB AHEAD OF PRINT. PMID: 36147011. BACKGROUND AND PURPOSE: THE NIMBUS STENT-RETRIEVER (NSR) WAS DEVELOPED FOR MECHANICAL THROMBECTOMY OF WALL-ADHERENT THROMBI IN CEREBRAL ARTERIES. IT FEATURES A NOVEL GEOMETRY WITH A PROXIMAL SPIRAL SECTION AND A DISTAL BARREL SECTION. THE NEW DEVICE IS DESIGNED TO RETRIEVE TOUGH CLOTS WITH A MICRO-CLAMPING TECHNIQUE. IN THE FIRST CASE SERIES REPORTING ON THE NSR, WE SHARE OUR INITIAL EXPERIENCE ABOUT THE FIRST 12 TREATED CASES. METHODS: IN TOTAL, 12 PATIENTS (5 MEN, 7 WOMEN; MEAN AGE 78 YEARS) WITH OCCLUSION OF THE INTERNAL CAROTID ARTERY OR THE MIDDLE CEREBRAL ARTERY (M1 OR M2 SEGMENT) WERE TREATED WITH THE NSR, 11 AFTER UNSUCCESSFUL RECANALIZATION ATTEMPTS WITH CONVENTIONAL STENT-RETRIEVERS OR ASPIRATION THROMBECTOMY. CERENOVUS DEVICES THAT WERE USED IN THIS STUDY: QTY 6 (EACH): EMBOTRAP III & NIMBUS (NSR). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH EMBOTRAP AND/OR NIMBUS DEVICES: QTY 1: SUBARACHNOID HEMORRHAGE (SAH); PATIENT # 6 (77/F): UNDERWENT THROMBECTOMY USING EMBOTRAP FOR 2X PASSES, THEN NIMBUS FOR 2X PASSES. THE PATIENT EXPERIENCED SAH AND FINAL OUTCOME WAS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229257 UNK_THROMBECTOMY NEURAVI CATHETER, THROMBUS RETRIEVER NRY NEURAVI LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death