BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 13688951 · Received March 8, 2022

    Report

    Report Number
    3008114965-2022-00176
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    October 8, 2020
    Report Date
    March 7, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: THACI B, NUÑO M, VARSHNEYA K, GERNDT CH, KERCHER M, DAHLIN BC, WALDAU B. THREE-DIMENSIONAL ANEURYSM VOLUME MEASUREMENTS SHOW NO CORRELATION BETWEEN COIL PACKING DENSITY AND RECURRENCE. HELIYON. 2020 OCT 8;6(10):E05170. DOI: 10.1016/J.HELIYON.2020.E05170. PMID: 33083618; PMCID: PMC7551363. THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. THE INITIAL REPORTER CONTACT INFORMATION IS NOT AVAILABLE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. 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 · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: THACI B, NUÑO M, VARSHNEYA K, GERNDT CH, KERCHER M, DAHLIN BC, WALDAU B. THREE-DIMENSIONAL ANEURYSM VOLUME MEASUREMENTS SHOW NO CORRELATION BETWEEN COIL PACKING DENSITY AND RECURRENCE. HELIYON. 2020 OCT 8;6(10):E05170. DOI: 10.1016/J.HELIYON.2020.E05170. PMID: 33083618; PMCID: PMC7551363. OBJECTIVE AND METHODS: ENDOVASCULAR TREATMENT IS THE MAINSTAY THERAPY FOR BRAIN ANEURYSMS. ABOUT 15% OF PATIENTS NEED RETREATMENT WITHIN SIX MONTHS DUE TO EARLY RECANALIZATION. THIS STUDY INVESTIGATES THE RISK FACTORS ASSOCIATED WITH TREATMENT FAILURE.: THIS RETROSPECTIVE COHORT STUDY INCLUDES ENDOVASCULARLY TREATED ANEURYSM CASES BETWEEN JULY 2012 AND DECEMBER 2015 AT THE UNIVERSITY OF CALIFORNIA DAVIS MEDICAL CENTER WITH PRE-TREATMENT AND EARLY POST-TREATMENT IMAGING. OF THE 50 PATIENTS WHO MET THE INCLUSION CRITERIA, 41 (82.0%) WERE FEMALE, WITH AN AVERAGE AGE OF 61 YEARS. MOST ANEURYSMS WERE ON THE ANTERIOR COMMUNICATING ARTERY (40%) OR POSTERIOR COMMUNICATING ARTERY (22.0%), AND 34 (68%) ANEURYSMS WERE RUPTURED. THE COILS USED WERE CERECYTE (CERENOVUS), AXIUM (MEDTRONIC) AND STRYKER NEUROVASCULAR. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (VRD) & CERECYTE COILS CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: AXIUM COILS (MEDTRONIC); STRYKER NEUROVASCULAR COILS; LVIS STENT (MICROVENTION); NEUROFORM EZ/EZ3 STENT (STRYKER); PIPELINE EMBOLIZATION DEVICE (MEDTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: PER TABLE 3, THERE WAS ONE PATIENT WHO RECEIVED AN ENTERPRISE STENT THAT EXPERIENCED EARLY ANEURYSM RECURRENCE, OR TREATMENT FAILURE. EARLY TREATMENT FAILURE WAS OBSERVED IN 14 ENDOVASCULARLY TREATED PATIENTS (10 COILING ONLY, 4 STENT-ASSISTED). ALTHOUGH ADVERSE EVENTS WERE NOTED, THE ARTICLE DOES NOT PROVIDE SUFFICIENT INFORMATION TO DETERMINE WHICH MANUFACTURER'S MEDICAL DEVICE IS ASSOCIATED WITH THE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338732 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AXIUM COILS (MEDTRONIC)| LVIS STENT (MICROVENTION)| NEUROFORM EZ/EZ3 STENT (STRYKER)| PIPELINE EMBOLIZATION DEVICE (MEDTRONIC)| STRYKER NEUROVASCULAR COILS