BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1052560 · Received May 22, 2008

    Report

    Report Number
    9616695-2008-00079
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 1, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT'S BODY. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT FRACTURE. TIME OF DEVICE MALFUNCTION: 16 MONTHS POST PROCEDURE. SYMPTOMS/AE: RESTENOSIS. IT WAS REPORTED THAT APPROXIMATELY 16 MONTHS POST LEFT INTERNAL CAROTID ARTERY XACT STENT IMPLANTATION, ANGIOGRAPHY REVEALED 80 PERCENT CAROTID ARTERY NARROWING SECONDARY TO STENT FRACTURE. THE INTIMA APPEARED TO BE UNAFFECTED, NO RESTENOSIS WAS APPARENT, AND NO THROMBUS WAS PRESENT. THE PT REPORTED THAT SHE WAS ABLE TO FEEL THE STENT IN THE ARTERY, BUT HAD NO OTHER SYMPTOMS. NO INTERVENTION WAS PERFORMED. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED NO ADDITIONAL INFO WAS PROVIDED. A CD WITH ANGIOGRAM RUNS WAS PROVIDED FOR REVIEW. ABBOTT'S REVIEW OF THE ANGIOGRAPHIC IMAGES REVEALED RESTENOSIS AT THE LEVEL OF THE STENT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 34124-66

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR