BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1221264 · Received November 5, 2008

    Report

    Report Number
    9616695-2008-00157
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 28, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. THE FIRST XACT STENT (LOT 36004-6G) IS BEING FILED UNDER MEDWATCH# 9616695-2008-00156.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: NONE. SYMPTOMS/AE: HYPOTENSION. TIME OF SYMPTOMS/AE: POST-PROCEDURE. IT WAS REPORTED THAT IN 2008, AN XACT STENT WAS SUCCESSFULLY IMPLANTED IN THE CRITICALLY STENOSED RIGHT INTERNAL CAROTID ARTERY (RICA). FOLLOW-UP CAROTID ULTRASOUND SHOWED ABRUPT INCREASE IN VELOCITIES IN THE RIGHT CAROTID AREA OF THE XACT STENT IMPLANT. CAROTID ARTERIOGRAM ON APPROX SEVEN MONTHS LATER, REVEALED GREATER THAN 90% RICA IN-STENT RESTENOSIS WITH STENT FRACTURE. THE PATIENT WAS ASYMPTOMATIC. ON TWO DAYS LATER, THE IN-STENT RESTENOSIS AND STENT FRACTURE WERE SUCCESSFULLY TREATED WITH ANGIOPLASTY AND XACT STENT (9X20) IMPLANTATION WITH 0% RESIDUAL STENOSIS. POSTPROCEDURALLY, THE PATIENT DEVELOPED HYPOTENSION THAT LASTED FOR MORE THAN 48 HOURS AND WAS TREATED WITH NEO-SYNEPHRINE DRIP AND MIDODRINE. THE PATIENT WAS DISCHARGED HOME ON THREE DAYS LATER. AT THE TIME OF DISCHARGE, HIS PREVIOUSLY PRESCRIBED ANTIHYPERTENSIVE MEDICATIONS WERE HELD. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NS 34100-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R BMW UNIVERSAL GUIDE WIRE| AGILTRAC BALLOON (X2)| TERUMO 0.035 STIFF GLIDE WIRE| VIATRAC PLUS BALLOON| SUPRACORE WIRE| 0.01 FR WIRE| 6 FR COOK SHUTTLE SHEATH| 5 FR AVANTI-CORDIS SHEATHS| .038 CORE J-MEDTRONIC WIRE| 6 FR AVANTI-CORDIS SHEATHS| ENCORE 26 INFLATION DEVICE| 5 FR VTK COOK CATHETER