BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1050248 · Received May 21, 2008

    Report

    Report Number
    3003681312-2008-00054
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATE 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 PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCT THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL WAS DEPLOYED IN THE RIGHT COMMON FEMORAL ARTERIOTOMY AND HEMOSTASIS WAS ACHIEVED. A TAXUS STENT WAS PLACED AND A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED PRIOR TO DEPLOYMENT. WHILE IN THE CATH LAB, THE PT WAS GIVEN 4600 UNITS OF UNFRACTIONATED HEPARIN (UFH). THE PT'S INR WAS 4.9; PT 45.7 AND PTT 64.6. SEVERAL HOURS PRIOR TO THE STENT PLACEMENT AND ANGIOGRAM, THE PT WAS SEEN IN THE EMERGENCY ROOM AND WAS GIVEN 324 MG OF ASPIRIN. THE PT WAS ON COUMADIN THERAPY TO PROTECT THE HEART VALVES. WHILE IN THE EMERGENCY ROOM, THE PT'S HEMOGLOBIN WAS 11.9 AND HEMATOCRIT 37.2. THE PT WAS TRANSFERRED TO THE CHEST PAIN UNIT AFTER THE STENT PLACEMENT AND ANGIO-SEAL DEPLOYMENT. APPROX 8 HOURS LATER, THE PT GOT UP AND DESCRIBED WHAT FELT LIKE A POP IN THE GROIN. APPROX 2 HOURS LATER, THE PT WAS BROUGHT BACK TO THE CATH LAB. THE HEMOGLOBIN WAS DROPPED TO 8.4 AND HEMATOCRIT TO 26.7. THE PT WAS INTUBATED AND 2 UNITS OF PACKED RED BLOOD CELLS AND 2 UNITS OF FRESH FROZEN PLASMA WERE GIVEN WITH THE INFUSION WIDE OPEN. THE DRESSING ON THE RIGHT GROIN WAS DRY AND INTACT. FIRMNESS WAS NOTED AT THE RIGHT GROIN EXTENDING TO THE RIGHT LOWER QUADRANT OF THE ABDOMEN. A VIABAHAN COVERED STENT WAS THEN PLACED IN THE RIGHT EXTERNAL ILIAC, VIA THE LEFT GROIN. TWO DAYS LATER, THE PT REMAINED HOSPITALIZED AND INTUBATED. THE PHYSICIAN VERBALIZED THAT HE SUSPECTED A DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL, PUERTO RICO NA 2067210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R CHRONIC COUMADIN THERAPY (DOSE UNK)