BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 2100802 · Received May 19, 2011

    Report

    Report Number
    2182269-2011-00087
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. 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. 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 NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS PERIPHERAL PROCEDURE A 6F ANGIO-SEAL EVOLUTION WAS DEPLOYED IN THE ARTERIOTOMY WITHOUT INCIDENT. THE PT RETURNED TO THE CATH LAB SEVERAL HOURS LATER WITH A COLD AND MOTTLED LEG. AN ANGIOGRAM REVEALED AN OCCLUSION IN THE POPLITEAL ARTERY AND LASER, CSI, AND ANGIOJET TREATMENTS WERE UTILIZED TO RESTORE BLOOD FLOW, BUT WERE UNSUCCESSFUL. THE PT UNDERWENT SURGICAL INTERVENTION WHERE A CLOT WAS REMOVED AND SENT TO PATHOLOGY FOR COMPOSITION ANALYSIS. THE PT IS REPORTED TO BE RECOVERING. THE PT HAS A MEDICAL HISTORY OF PERIPHERAL VASCULAR DISEASE IN BILATERAL ILIAC ARTERIES. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL EVOLUTION MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R