BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1081657 · Received July 23, 2008

    Report

    Report Number
    2182269-2008-00184
    Event Type
    Injury
    Date Received
    July 23, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATE THAT IF COLLAGEN DEPOSITION INTO THE ARTERY OR THOMBUS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AN ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED MILD TORTUOSITY AT THE PUNCTURE SITE. THE ANGIO-SEAL WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. ONE DAY LATER, THE PT WAS DISCHARGED. ON AN UNKNOWN DATE, THE PT RETURNED TO THE HOSP AND COMPLAINED OF LEG PAIN. THERE WAS ALMOST NO PERIPHERAL BLOOD FLOW PRESENT. SEVEN DAYS LATER, COLLAGEN WAS CONFIRMED INSIDE THE ARTERY CAUSING OCCLUSION IN THE COMMON ILIAC ARTERY. UNDER LOCAL ANESTHESIA, SURGERY WAS PERFORMED TO REMOVE THE DEVICE. THE PT HAS RECOVERED AND HAS BEEN DISCHARGED FROM THE HOSP. THREE MONTHS LATER, A FOLLOW-UP ANGIOGRAM WAS PERFORMED FOR LESION IN THE PERIPHERAL ARTERY BUT NO ANOMALIES AT THE PUNCTURE SITE WERE IDENTIFIED. ONE DAY LATER, THE PT WAS DISCHARGED. THE EVENT DATE IS 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 8F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 2043372

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention