BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 875158 · Received July 3, 2007

    Report

    Report Number
    2953144-2007-00833
    Event Type
    Injury
    Date Received
    July 3, 2007
    Date of Event
    May 1, 2007
    Report Date
    June 18, 2007
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THERE WAS NO LOT INFO. WE WERE NOT ABLE TO PERFORM DEVICE INSPECTION OR DEVICE HISTORY RECORD REVIEW IN THIS CASE. SEE SCANNED PAGES

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNK CLOSURE FAILURE. SYMPTOMS/AE: PSEUDOANEURYSM, MEDIAN NEUROPATHY. TIME OF SYMPTOMS/AE: POST-PROCEDURE. IT WAS REPORTED IN A LITERATURE REPORT THAT THE PHYSICIAN ATTEMPTED UNSUCCESSFUL BRACHIAL ARTERIOTOMY CLOSURE USING AN UNK PERCLOSE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. THIS RESULTED IN A PSEUDOANEURYSM THAT REQUIRED IMMEDIATE POSTOPERATIVE SURGICAL REPAIR. THE PT SUBSEQUENTLY DEVELOPED CHRONIC IMBALANCE, POSITIONAL DIZZY SPELLS, AND DISABLING MEDIAN NEUROPATHY IN HIS DOMINANT HAND. NO ADD'L INFO IS AVAILABLE. THE ARTICLE REFERENCED IS TITLED: BASILAR ARTERY STENT ANGIOPLASTY FOR SYMPTOMATIC INTRACRANIAL ATHERO-OCCLUSIVE DISEASE: COMPLICATIONS AND LATE MIDTERM CLINICAL OUTCOMES. AJNR AMJ NEURORDIOL 2007 28: 808-815.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention| S WARFARIN| CLOPIDOGREL| HEPARIN| UNK STENT| UNK OTW DILATATION BALLOON