BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1001534 · Received February 21, 2008

    Report

    Report Number
    2953144-2008-00086
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 28, 2008
    Manufacturer
    ABBOTT VASCULAR , VASCULAR SOLUTIONS-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PT AND DEVICE INFO. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: VESSEL OCCLUSION, LIMB PULSE DEFICIT. TIME OF SYMPTOMS/AE: AFTER VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC CEREBRAL ANGIOGRAM. REPORTEDLY, IMMEDIATELY AFTER CLIP DEPLOYMENT, THE PT DEVELOPED HEAVINESS IN THE CLOSURE LEG. NO TREATMENT WAS PROVIDED AT THAT TIME. ONE HOUR LATER, THE LIMB DEVELOPED PULSE DEFICIT. AN ANGIOGRAM WAS PERFORMED REVEALING AN OCCLUSION AT THE CLOSURE SITE. REVASCULARIZATION OF THE VESSEL WAS ATTEMPTED ANGIOPLASTY AND THROMBECTOMY SYSTEM. BOTH PROVIDED SUBOPTIMAL RESULTS; THEREFORE, A NON-ABBOTT STENT WAS IMPLANTED. FOLLOW-UP ANGIOGRAM REVEALED GOOD MORPHOLOGIC RESULTS. THE PT EXPERIENCED NO RESIDUAL SYMPTOMS AND WAS DISCHARGED TO HOME THE NEXT DAY. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR , VASCULAR SOLUTIONS-REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention STENT: ZILVER