BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1940510 · Received December 21, 2010

    Report

    Report Number
    3003681312-2010-00079
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    May 20, 2009
    Report Date
    December 21, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVAL COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG 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 DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT AN AVE FISTULA OR PSEUDOANEURYSM IS POSSIBLE RISKS OR SITUATIONS ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURE. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES.

    Description of Event or Problem · 1

    THE PT PHONED SJM TO REPORT THAT IN 2009 AN ANGIO-SEAL DEVICE WAS USED ON HIM FOLLOWING A SINGLE CORONARY STENTING PROCEDURE USING THE RIGHT GROIN SITE. THE PT HAD A LEFT HEART CATHETERIZATION. THE PHYSICIAN NOTED TO DO THE RECOMMENDED RIGHT FEMORAL ANGIOGRAM WITHOUT COMPLICATION. THE POST-PROCEDURE COURSE WAS UNEVENTFUL AND THE PT STATED THE PHYSICIAN WAS PLEASED WITH THE RESULTS. THE FOLLOWING MORNING, HE BEGAN TO AMBULATE AND WAS DISCHARGED. ON (B)(6) 2010, THE PT REVISITED THE PHYSICIAN DUE TO RIGHT GROIN PAIN. THE PT EXPERIENCED HEAVINESS IN HIS LEG AND NOTICED SIGNIFICANT SWELLING AT THE PUNCTURE SITE WITH BLEEDING. THE NURSE PRACTITIONER REPORTED THAT THE PT WAS TENDER IN THE RIGHT GROIN WITH ASSOCIATED BRUIT. SHE SENT HIM TO VASCULAR LAB AND THEY REPORTED 1.5 X 1.8 CM PSEUDOANEURYSM WITH FEEDER TO THE RCFA WITH POSSIBLE DVT. HEPARIN WAS STARTED AND THE PT UNDERWENT SURGERY. ACCORDING TO THE PT, THE SURGEON ALLEGEDLY REMOVED 3 PIECES OF THE ANGIO-SEAL (ONE PIECE HAD BROKEN INTO 2 PIECES) AND NO DVT WAS PRESENT. THE PT WAS ECCHYMOTIC FROM HIS KNEE TO HIS LOWER ABDOMEN FOLLOWING THE EVENT. THE PT STATED HE HAS BEEN SEEN IN THE ER FOR CHEST PAIN AND SOB TWICE SINCE HIS STENTING AND UNDERWENT HEART CATHETERIZATION A FEW MONTHS FOLLOWING HIS INITIAL PROCEDURE, USING THE OPPOSITE GROIN AS ACCESS SITE. NO ASD WAS USED. ACCORDING TO THE PT, THE HOSPITAL REPORTED THE EXPLANTED COMPONENTS WERE DISCARDED. THE PT WAS REPORTED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 2739292

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R