BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1790103 · Received August 5, 2010

    Report

    Report Number
    2182269-2010-00133
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    May 1, 2010
    Report Date
    August 5, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION 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 IFU CAUTIONS IF ANCHOR FRACTURE OR EMBOLISM IS SUSPECTED, THE DEVICE SHOULD BE EXAMINED TO DETERMINE IF THE ANCHOR HAS BEEN WITHDRAWN. IF BLEEDING OCCURS, APPLY MANUAL OR MECHANICAL PRESSURE TO THE PUNCTURE SITE PER STANDARD PROCEDURES. IF ANCHOR IS NOT ATTACHED TO THE DEVICE, MONITOR PATIENT (FOR AT LEAST 24 HOURS) FOR SIGNS OF VASCULAR OCCLUSION. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE (PCI), AN 8F VIP ANGIO-SEAL WAS SELECTED FOR USE TO CLOSE THE 7F FEMORAL PUNCTURE. AN ANGIOGRAM OF THE FEMORAL ARTERY REVEALED NO ANOMALIES. INSTANT HEMOSTASIS WAS NOT ACHIEVED AND MANUAL COMPRESSION WAS APPLIED. ONE DAY LATER, THE PATIENT EXPERIENCED ISCHEMIA IN THE LEG AND WAS DISCHARGED FROM THE HOSPITAL. THREE WEEKS LATER AT ANOTHER HOSPITAL, THROMBUS WAS ASPIRATED AND A STENT WAS PLACED IN THE POPLITEAL ARTERY WITH SUBOPTIMAL RESULT. ALLEGEDLY, THE CAUSE OF THE ISCHEMIA WAS DUE TO THE DETACHED ANCHOR. THE EVENT DATE AND IMPLANT DATES ARE MONTH SPECIFIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R