BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 2040998 · Received March 23, 2011

    Report

    Report Number
    2182269-2011-00051
    Event Type
    Injury
    Date Received
    March 23, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A LITERATURE ARTICLE FROM THE JOURNAL OF INVASIVE CARDIOLOGY, VOLUME 23 ISSUED MARCH 2011, AN ANGIO-SEAL WAS DEPLOYED AFTER A ROUTINE ANGIOGRAPHY. IMMEDIATELY FOLLOWING DEPLOYMENT, MANUAL COMPRESSION WAS REQUIRED TO ACHIEVE HEMOSTASIS. A PATIENT PRESENTED WITH UNILATERAL LEG CRAMPS ONE WEEK AFTER ANGIO-SEAL DEPLOYMENT. WHEN THE PATIENT WAS SEEN IN THE CARDIOLOGY CLINIC, A MAGNETIC RESONANCE IMAGING ANGIOGRAM WAS REQUESTED, WHICH SHOWED A FILLING DEFECT IN THE RIGHT POPLITEAL ARTERY. ALLEGEDLY, THE COLLAGEN HAD EMBOLIZED AND WAS SUBSEQUENTLY REMOVED BY A VASCULAR SURGEON. THE PATIENT WAS REPORTED TO BE FINE POST SURGERY WITHOUT ANGINA AND CLAUDICATION. THE IMPLANT, EXPLANT, AND EVENT DATES ARE UNKNOWN. ADDITIONAL INFORMATION WAS NOT AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R CLOPIDOGREL (DOSAGE UNKNOWN)