BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1357807 · Received April 7, 2009

    Report

    Report Number
    2953144-2009-00384
    Event Type
    Injury
    Date Received
    April 7, 2009
    Date of Event
    March 19, 2009
    Report Date
    March 26, 2009
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED; WITHOUT DEVICE INVESTIGATION, A SPECIFIC ROOT CAUSE FOR THE FAILURE TO ACHIEVE HEMOSTASIS COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE RX ACCUNET (PART 1011649-75, LOT 8012851), IS BEING REPORTED UNDER MEDWATCH #3004742046-2009-00073.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNK. SYMPTOM/AE: FAILURE TO ACHIEVE HEMOSTASIS. TIME OF SYMPTOM/AE: DURING/POST-PROCEDURE. IT WAS REPORTED THAT DURING/POST A LEFT INTERNAL CAROTID ARTERY (LICA) STENTING PROCEDURE, THE PT EXPERIENCED A STROKE. A RX ACCUNET EMBOLIC PROTECTION DEVICE (EPD) WAS POSITIONED, AND A RX ACCULINK STENT WAS IMPLANTED IN THE LICA. DURING POSTDILATATION, USING A VIATRAC 14 PLUS BALLOON, THE PT EXPERIENCED BRADYCARDIA THAT RESOLVED IMMEDIATELY AFTER BALLOON DILATATION. AFTER THE EPD WAS REMOVED, ANGIOGRAPHY SHOWED 20%, ECCENTRIC, RESIDUAL STENOSIS. ADDITIONAL POST-DILATATION WAS CONSIDERED; THEREFORE, A SECOND RX ACCUNET EPD (PART 1011649-75, LOT 8012851) WAS ADVANCED AND POSITIONED. AN UNIDENTIFIED BALLOON DID NOT CROSS THE STENT AND POST-DILATATION WAS ABANDONED. THE EPD WAS REMOVED AND THE PROCEDURE WAS COMPLETED. IMMEDIATELY POST-PROCEDURE, IT WAS NOTICED THAT THE PATIENT HAD RIGHT SIDED HEMIPARESIS. CT/ANGIOGRAM OF THE HEAD SHOWED AN ACUTE LACUNAR INFARCT. LEFT MIDDLE CEREBRAL ARTERY THROMBOLYSIS WITH TISSUE PLASMINOGEN ACTIVATOR WAS PERFORMED. FEMORAL ARTERIOTOMY CLOSURE WAS ATTEMPTED USING A STARCLOSE DEVICE; HOWEVER, THERE WAS AN UNSPECIFIED MECHANICAL FAILURE AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION AND A FEMSTOP DEVICE. THE PT'S HEMIPARESIS IMPROVED AND HE WAS DISCHARGED TO REHABILITATION. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention HEPARIN| VIATRAC 14 PLUS 5X30MM BALLOON| RX ACCULINK STENT| RX ACCUNET (X2)| 6F SHUTTLE SHEATH| VIATRAC 14 PLUS 7X40 BALLOON