BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1937241 · Received December 23, 2010

    Report

    Report Number
    3004742046-2010-00645
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EMBOLIC PROTECTION: RX ACCUNET (1011649-75, LOT # 0011451), HEPARIN. INACCURATE DELIVERY CAN BE THE RESULT OF, BUT NOT LIMITED TO, INTERACTION WITH LESION/ANATOMY, PHYSICIAN TECHNIQUE, SHEATH DAMAGE, AND/OR DAMAGE TO THE HANDLE COMPONENTS. WITHOUT RETURN OF THE PRODUCT, A DEFINITIVE CAUSE FOR THE REPORTED DEPLOYMENT ISSUES CANNOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY FINDINGS RELEVANT TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT THE ACCULINK STENT WAS INACCURETLY IMPLANTED ABOVE THE RIGHT COMMON CAROTID ARTERY TARGET LESION REQUIRING THE IMPLANTATION OF AN OVERLAPPING SECOND ACCULINK STENT TO COVER THE REST OF THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-VS 9060451

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention