BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2190969 · Received July 28, 2011

    Report

    Report Number
    2182269-2011-00125
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. 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 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) CAUTIONS THE USE OF THE ANGIO-SEAL DEVICE IN PTS WITH CLINICALLY SIGNIFICANTLY PERIPHERAL VASCULAR DISEASE. ACCORDING TO THE IFU, THE SAFETY AND EFFECTIVENESS OF THE ANGIO-SEAL HAS NOT BEEN ESTABLISHED IN PTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF PT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PT ARTERIES > 5 MM DIAMETER WHEN THERE IS FOUND TO BE LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE.

    Description of Event or Problem · 1

    FOLLOWING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI), AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED A LEFT COMMON FEMORAL ARTERY (LCFA) PUNCTURE WITH MILD CALCIFICATION. AN (B)(4) SHEATHLESS PV GUIDING CATHETER AND 7F MEDKIT SHEATH INTRODUCER WERE USED AS A PROCEDURE SHEATH. IT WAS ALSO REPORTED THAT MULTIPLE PUNCTURES AT THE LCFA WERE MADE DURING THE PPI. FOLLOWING AN ALLEGEDLY UNCOMFORTABLE DEPLOYMENT, HEMOSTASIS WAS NOT COMPLETELY ACHIEVED. MANUAL COMPRESSION WAS APPLIED FOR THREE MINS. THE PT COMPLAINED OF A COLD LEG ON THE SIDE OF THE ANGIO-SEAL IMPLANT. THE PT HAD ABSENT PULSES ON THE AFFECTED SIDE AT THE DORSALIS PEDIS ARTERY. AN ANGIOGRAM REVEALED A COMPLETE OCCLUSION AT THE PUNCTURE SITE. A PERCUTANEOUS OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO TREAT THE OCCLUSION BUT IT WAS NOT SUFFICIENT. THE PT UNDERWENT SURGERY AND TOLERATED THE PROCEDURE WELL. THE ANGIO-SEAL WAS REMOVED. THE PT WAS IN GOOD CONDITION FOLLOWING THE EVENT AND IS REPORTEDLY STABLE AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 3347594

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R ANTICOAGULANTS (TYPE AND DOSAGES UNK)| SARPOGRELATE HYDROCHLORIDE