BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 1241292 · Received November 20, 2008

    Report

    Report Number
    2182269-2008-00325
    Event Type
    Injury
    Date Received
    November 20, 2008
    Report Date
    November 20, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATE THAT IF COLLAGEN DEPOSITION INTO THE ARTERY OR THROMBOSIS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) INSTRUCT THE USER ONCE A FULL REAR LOCK HAS BEEN ACHIEVED, AND THE DEVICE IS BEING DEPLOYED, DO NOT RE-INSERT THE DEVICE; RE-INSERTION OF THE DEVICE AFTER PARTIAL DEPLOYMENT COULD CAUSE COLLAGEN TO ENTER THE ARTERY. ALSO, FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE COMPACTING THE COLLAGEN COULD CAUSE COLLAGEN TO ENTER THE ARTERY. ALSO ERRATIC, VIGOROUS TAMPING OR EXCESSIVE UPWARD TENSION ON THE SUTURE MAY RESULT IN COLLAGEN PLACEMENT IN THE ARTERY OR ANCHOR BREAKAGE. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) WARNS; TO NOT USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS AT OR DISTAL TO THE BIFURCATION OF THE SUPERFICIAL FEMORAL AND PROFUNDA FEMORIS ARTERY. THIS MAY RESULT IN THE ANGIO-SEAL DEVICE ANCHOR CATCHING ON THE BIFURCATION OR BEING POSITIONED INCORRECTLY, AND/OR COLLAGEN DEPOSITION IN THE VESSEL. THESE EVENTS MAY REDUCE BLOOD FLOW THROUGH THE VESSEL LEADING TO SYMPTOMS OF DISTAL ARTERIAL INSUFFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PRINTED LITERATURE ARTICLE THAT AN ANGIO-SEAL WAS DEPLOYED IN THE RIGHT GROIN POST UNSUCCESSFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. ONE WEEK LATER, A CT ANGIOGRAM REVEALED A NEAR OCCLUSION PROXIMAL TO THE FEMORAL BIFURCATION. THE PATIENT'S ANKLE BRACHIAL INDEX AT REST WAS 0.61 AND 0.30 AFTER EXERCISE. SIX DAYS LATER, EXPLORATION WAS PERFORMED WHICH REVEALED FIBROTIC TISSUE IN FRONT OF THE FEMORAL ARTERIES. AFTER ARTERIOTOMY, THE ENTIRE ANGIO-SEAL DEVICE WAS FOUND INTRALUMINALLY IN THE DISTAL COMMON FEMORAL ARTERY. THERE WERE NO OTHER STENOTIC LESION PRESENT. AN ENDARTERECTOMY AND DACRON PATCH ANGIOPLASTY WERE PERFORMED. LATER, THE PATIENT'S SYMPTOMS DISAPPEARED AND THE ANKLE BRACHIAL INDEX NORMALIZED. THE IMPLANT, EXPLANT AND EVENT DATE ARE UNKNOWN. THE ANGIO-SEAL DEPLOYER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL DEVICE ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention