BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1071317 · Received July 8, 2008

    Report

    Report Number
    9616695-2008-00107
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A F/U WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: POOR WALL APPOSITION OF STENT. TIME OF DEVICE MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: HYPOTENSION. TIME OF SYMPTOMS/AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, AFTER THE XACT STENT WAS PLACED, THERE WAS POOR WALL APPOSITION OF THE XACT STENT AND THE VESSEL LUMEN WAS NOT FULLY OPEN AFTER DEPLOYMENT. POST-DILATATION WAS PERFORMED, BUT THIS DID NOT RESOLVE THE PROBLEM. A SECOND XACT STENT WAS SUCCESSFULLY DEPLOYED WHICH ASSISTED IN APPOSING THE STENT TO THE VESSEL WALL AND FURTHER OPENING THE LUMEN. ADDITIONALLY, DURING THE PROCEDURE, THE PT EXPERIENCED VISION LOSS IN THE RIGHT EYE SECONDARY TO HYPOTENSION AND WAS TREATED WITH A NEOSYNEPHRINE INFUSION. THE VISION LOSS RESOLVED THE SAME DAY ONCE THE BLOOD PRESSURE INCREASED. THE PT WAS SEEN BY A NEUROLOGIST AND REPORTEDLY THE NEUROLOGICAL ISSUE WAS RELATED TO THE HYPOTENSION. THERE WERE NO FURTHER REPORTED NEUROLOGICAL ISSUES. THE NEOSYNEPHRINE DRIP WAS DISCONTINUED 2 DAYS LATER, BUT THE BLOOD PRESSURE REMAINED LABILE. THE PT WAS TREATED WITH BOTH VASOTEC FOR HYPERTENSION AND SUDAFED FOR HYPOTENSION. THE PT REMAINED IN THE HOSP FOR MONITORING OF BLOOD PRESSURE AND WAS DISCHARGE TO HOME 5 DAYS POST PROCEDURE. ALTHOUGH REQUESTED, THERE IS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 385236G

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EMBOSHIELD| UNK SLIP CATHETER| HEPARIN