BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2770294 · Received September 28, 2012

    Report

    Report Number
    2182269-2012-00104
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. 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 PROCEDURES. 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. THE ANGIO-SEAL DEVICE INSTRUCTION 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) INSTRUCTIONS 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. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USE OF THE ANGIO-SEAL DEVICE IN PTS UNDERGOING THERAPEUTIC THROMBOLYSIS.

    Description of Event or Problem · 1

    THE PT UNDERWENT A PERIPHERAL INTERVENTION TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) STENOSIS AT THE JUNCTURE OF THE SFA AND A TIBIAL GRAFT IN THE RIGHT LEG. ACCESS WAS VIA AN ANTEGRADE PUNCTURE TO THE RIGHT FEMORAL ARTERY. AT THE CONCLUSION OF THE CASE, A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE RESULTS INDICATED THAT THOUGH THE ANTEGRADE PUNCTURE WAS DIFFICULT TO SEE, THE VESSEL WAS OF ADEQUATE SIZE AND HEALTHY. A 6F ANGIO-SEAL VIP WAS SUCCESSFULLY DEPLOYED AND HEMOSTASIS WAS IMMEDIATE. THE NEXT DAY, WHILE AT HOME, THE PT WAS BEARING DOWN AND FELT A DULL PAIN IN THE GROIN AND BEGAN TO BLEED FROM THE ACCESS SITE. IN THE EMERGENCY ROOM, COMPUTED TOMOGRAPHY (CT) REVEALED AN ANTERIOR FEMORAL HEMATOMA AND A RETROPERITONEAL HEMATOMA. AFTER TWO HOURS OF MANUAL PRESSURE, THE PT WENT FOR SURGICAL INTERVENTION. THE COLLAGEN PORTION OF THE ANGIO-SEAL DEVICE WAS CAUGHT ON THE INGUINAL LIGAMENT AND THE SUTURE HAD PROCEEDED INTO THE ARTERY. A SMALL PIN HOLE BLEED WAS FOUND AND CLOSED WITH TWO SUTURES. THE LOCATION OF THE ANGIO-SEAL ANCHOR WAS NOT DETERMINED. LATER THAT EVENING, NO PULSES WERE EVIDENT IN THE RIGHT LEG AND THE PT WAS TAKEN FOR A THROMBECTOMY PROCEDURE. THE PHYSICIAN GAINED ACCESS VIA THE LEFT COMMON FEMORAL ARTERY (LCFA), BUT WAS UNABLE TO ACCESS THE RIGHT FEMORAL ARTERY DUE TO STENTS AT THE BIFURCATION OF THE AORTA AND THE ILIAC ARTERIES. HEPARIN ADMINISTRATION WAS INITIATED FOR HYPERCOAGULATION. FOLLOWING THE FAILED ATTEMPT AT A PERCUTANEOUS INTERVENTION TO TREAT A VESSEL OCCLUSION IN THE RIGHT LEG, THE PHYSICIAN DEPLOYED A 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE IN THE LEFT COMMON FEMORAL ARTERY (LCFA); HOWEVER, HEMOSTASIS WAS NOT IMMEDIATE AND MANUAL COMPRESSION WAS HELD FOR FIFTEEN MINS. THE ACTIVATED COAGULATION TIME (ACT) PRIOR TO DEPLOYMENT WAS 300 SECONDS. THE NEXT MORNING, THE PT WAS TAKEN TO THE OPERATING ROOM (OR) FOR A SECOND UNSUCCESSFUL THROMBECTOMY, EXPERIENCED A MYOCARDIAL INFARCTION, AND SUBSEQUENTLY DEVELOPED ANOTHER BLEED, WHICH WAS ATTRIBUTED TO ANTICOAGULATION. A THIRD ATTEMPT AT RESOLVING THE VESSEL OCCLUSION WAS UNSUCCESSFUL AS WELL. THE PT UNDERWENT A BELOW THE KNEE AMPUTATION, AND RECOVERED IN THE HOSPITAL WITH NO FURTHER COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R METOPROLOL (50MG TWICE DAILY)| ASPIRIN (80MG/DAY)| NITROGLYCERIN PATCH (0.6MG/DAILY)| CRESTOR (20MG/DAY)| PLAVIX (75MG/DAY)