BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1923703 · Received December 9, 2010

    Report

    Report Number
    3003681312-2010-00076
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 27, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ANCHOR, COLLAGEN FRAGMENT, AND SUTURE SEGMENT, CONSISTENT WITH COMPONENTS USED IN THE ANGIO-SEAL DEVICE, WERE VISUALLY INSPECTED. THE ANCHOR AND COLLAGEN FRAGMENT WERE SECURED BY AN INTACT SUTURE LOOP APPROXIMATELY 0.3" IN LENGTH (STRETCHED). THE ANCHOR LEGS WERE CURVED AWAY FROM THE ANCHOR DOME INTO A "U" SHAPE, CONSISTENT WITH EXPOSURE TO HEAT/MOISTURE AND EXTERNAL FORCES. NO CONTRIBUTING VISUAL ANOMALIES WERE NOTED. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE INCIDENT WAS DUE TO AN INTRINSIC DEFECT IN THE ANGIO-SEAL DEVICE, AS SUPPORTED BY THE REVIEW OF THE MANUFACTURING TRAVELER AND THE ANALYSIS PERFORMED. THE CAUSE OF THE REPORTED INCIDENT REMAINS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATE THAT THE ANGIO-SEAL DEVICE IS INDICATED FOR USE IN CLOSING AND REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY PROCEDURES OR INTERVENTIONAL PROCEDURES. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) PRECAUTION THE USE OF THE ANGIO-SEAL IN PEDIATRIC PATIENTS OR OTHERS WITH SMALL FEMORAL ARTERY SIZE (< 4MM IN DIAMETER). SMALL FEMORAL ARTERY SIZE MAY PREVENT THE ANGIO-SEAL ANCHOR FROM DEPLOYING PROPERLY IN THESE PATIENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS BEING TREATED FOR SUBCLAVIAN ARTERY STENOSIS THROUGH A 6F BRACHIAL ARTERY AND AN ANGIO-SEAL WAS SELECTED FOR CLOSURE. POST PROCEDURE, THE PHYSICIAN COMMENTED THAT THE RADIAL PULSE WAS NOT AS ROBUST AS EXPECTED AND THE PATIENT WAS ALSO STATING THAT THEY HAD ARM PAIN. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT FOR MONITORING. THE FOLLOWING DAY, THE RADIAL PULSE HAD NOT IMPROVED, SO AN ULTRASOUND WAS PERFORMED. THE RESULTS REVEALED AN OCCLUSION AT THE PUNCTURE SITE. THE PATIENT WAS TAKEN TO SURGERY FOR ANGIO-SEAL REMOVAL AND ARTERY RECONSTRUCTION. SURGICAL RESULTS REVEALED THAT THE COLLAGEN WAS OUTSIDE OF THE ARTERY AND THE ANCHOR INSIDE THE ARTERY. ALLEGEDLY, THE ANCHOR WAS DISFIGURED AND WAS CURVED AWAY FROM THE INTIMA OF THE ARTERY. THE ARTERY WAS DISSECTED AND THE SURGEON COMMENTED THAT THE ANCHOR COULD HAVE HIT AN ARTERY BRANCH DURING DEPLOYMENT AND TORE THE INTIMA. THE VESSEL WAS ALSO NOTED TO BE SMALLER, BEING 2 MM IN SIZE. THE PATIENT WAS TAKING PRESCRIBED ANTICOAGULANTS (TYPE AND DOSAGE UNKNOWN). ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3150485

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R