BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1221263 · Received November 5, 2008

    Report

    Report Number
    9616695-2008-00156
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 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
    NJ, 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. ANGIOGRAM IMAGES, DATED 2008, PROVIDED TO ABBOTT WERE MEDICALLY REVIEWED AND REVEALED THE STENT WAS FRACTURED AT MID-LEVEL. IT COULD NOT BE SEEN WHETHER THE STENT WAS BROKEN INTO TWO PIECES; HOWEVER, SEVERAL STRUTS ADJACENT TO EACH OTHER WERE CIRCUMFERENTIALLY FRACTURED. THERE APPEARED TO BE IN-STENT INTIMAL HYPERPLASIA IN THE MIDDLE OF THE STENT. THE SECOND XACT 9.0X20MM STENT (LOT 34100-6G) IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE #1 MALFUNCTION: IN-STENT RESTENOSIS, STENT FRACTURE. TIME OF MALFUNCTION: APPROXIMATELY 7 MONTHS POST PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT ON 03/07/08, 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 10/15/08 REVEALED GREATER THAN 90% RICA IN-STENT RESTENOSIS WITH STENT FRACTURE. THE PATIENT WAS ASYMPTOMATIC. IN 2008, 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 NA 36004-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R