BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 1241289 · Received November 20, 2008

    Report

    Report Number
    2182269-2008-00309
    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 DEVICE INSTRUCTION FOR USE (IFU) CAUTION, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. 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 INSTRUCTION FOR USE (IFU) INSTRUCT THE USER NOT TO USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS PROXIMAL TO THE INGUINAL LIGAMENT AS THIS MAY RESULT IN A RETROPERITONEAL BLEED.

    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 CAROTID ARTERY STENTING. IMMEDIATELY THEREAFTER, THE PATIENT'S WALKING DISTANCE ABILITY WAS SEVERELY IMPAIRED. A NON-INVASIVE ANGIOGRAM REVEALED A SHORT OCCLUSION AT THE TRANSITION ZONE BETWEEN THE EXTERNAL ILIAC ARTERY AND THE COMMON FEMORAL ARTERY. THE PATIENT UNDERWENT SURGERY WHERE COLLAGEN WAS FOUND INTRALUMINALLY AT THE LEVEL OF THE INGUINAL LIGAMENT AND SUBSEQUENTLY REMOVED. THERE WAS NO STENOTIC ATHEROSCLEROTIC LESIONS IN THE COMMON FEMORAL ARTERY. AFTERWARDS, THE PATIENT'S SYMPTOMS DISAPPEARED AND THE ANKLE BRACHIAL INDEX NORMALIZED. THE IMPLANT 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 UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention