BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1831799 · Received September 8, 2010

    Report

    Report Number
    9616695-2010-00039
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT FRACTURE CAN BE A RESULT OF, BUT IS NOT LIMITED TO, ANATOMICAL CONDITIONS (TORTUOSITY/CALCIFICATION), STENT MATERIAL, POST DILATATION TECHNIQUE, ANATOMICAL MOTION RESULTING IN STRESS/FATIGUE OF THE STENT MATERIAL AND/OR INTERACTION WITH OTHER DEVICES POST DEPLOYMENT. THE STENT FRACTURE WAS NOT NOTED AT THE TIME OF STENT IMPLANT, SUGGESTING THAT THE NOTED DAMAGE OCCURRED POST PROCEDURE. HOWEVER, A DEFINITIVE CAUSE FOR THE REPORTED STENT FRACTURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT FRACTURE. TIME OF DEVICE ISSUE: POST PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED VIA A TRIAL THAT 3 YEARS POST STENT IMPLANTATION IN THE RIGHT INTERNAL AND COMMON CAROTID ARTERIES FOLLOW-UP X-RAY REVEALED A GRADE 4 TRANSVERSE, DISTAL STENT FRACTURE WITH COMPONENTS MALALIGNED. NO RESTENOSIS WAS OBSERVED AND THE PATIENT WAS ASYMPTOMATIC. NO TREATMENT IS PLANNED. 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-VASCULAR SOLUTIONS NA 31021-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR GUIDE CATH: COOK| EMBOSHIELD (E6190-01, LOT # 0511394)| ANGIOMAX| SHEATH: BSC| VESSEL CLOSURE: ANGIOSEAL| GUIDE WIRE: WHOLEY, COOK LOC| DILATATION CATHETER: VIATRAC (X2)