BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1111724 · Received August 11, 2008

    Report

    Report Number
    9616695-2008-00120
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. NEUROLOGICAL EVENT, ARRHYTHMIA AND HYPOTENSION MAY OCCUR DURING THIS TYPE OF PROCEDURE, AS STATED IN THE INSTRUCTIONS FOR USE. THE NEUROLOGICAL EVENT, ARRHYTHMIA AND HYPOTENSION ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE USE OF THE DEVICE. THE REPORTED HOSPITALIZATION WAS IN RESPONSE TO THE OBSERVED PT EFFECTS. IN ADDITION, NO DEVICE MALFUNCTION WAS REPORTED. INFO AVAILABLE IN THE CASE DESCRIPTION IS NOT SUFFICIENT TO DETERMINE RELATION BETWEEN THE EVENT AND THE ABBOTT VASCULAR DEVICE QUALITY.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: HYPOTENSION, STROKE, VENTRICULAR FIBRILLATION. TIME OF SYMPTOMS/AE: DURING THE PROCEDURE. IT WAS REPORTED THAT IMMEDIATELY FOLLOWING A RIGHT CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE AND DURING A LEFT INTERNAL CAROTID ARTERY (ICA) STENTING PROCEDURE, AT THE TIME OF THE XACT STENT DEPLOYMENT, THE PT EXPERIENCED PROFOUND HYPOTENSION, COMPLAINED OF NOT FEELING WELL, DEMONSTRATED RIGHT UPPER EXTREMITY WEAKNESS, AND DEVELOPED VENTRICULAR FIBRILLATION. THE PT WAS DEFIBRILLATED SUCCESSFULLY, INTUBATED FOR AIRWAY PROTECTION, ADMINISTERED FLUIDS AND MEDICATIONS, AND TAKEN FOR AN EMERGENCY CT SCAN OF THE HEAD WHICH INITIALLY REPORTED NO HEMORRHAGE OR INFARCT SEEN. HOWEVER, TWO DAYS LATER THE CT SCAN OF THE HEAD REVEALED A STROKE. THE PT WAS DISCHARGED TO HOME 2008. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 418850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S TAD2| SHEATH: SHUTTLE SHEATH| SPYDERX| EPD: EMBOSHIELD| GUIDE CATH: BENTSON| VIATRAC| DIL CATH: MAVERICK X 2| GUIDE WIRE: BALANCE MIDDLEWEIGHT WIRE| BIVALIRUDIN