BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL STS PLUS DEVICE

    MDR report key: 1241302 · Received November 20, 2008

    Report

    Report Number
    2182269-2008-00319
    Event Type
    Injury
    Date Received
    November 20, 2008
    Report Date
    November 20, 2008
    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 FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PRINTED LITERATURE ARTICLE THAT THE PATIENT WAS TREATED FOR STENOSIS ON DUPLEX GRAFT SURVEILLANCE 10 WEEKS FOLLOWING ANGIOPLASTY OF A STENOSIS IN A DISTAL FEMORAL VEIN GRAFT. A FILLING DEFECT WAS IDENTIFIED ON THE ANGIOGRAM PERFORMED BY A CONTRALATERAL FEMORAL PUNCTURE. THIS WAS PRESUMED TO BE DUE TO THE ANGIO-SEAL ANCHOR AND WAS BALLOON DILATED SATISFACTORILY WITH NO SIGNIFICANT RESIDUAL STENOSIS ON DUPLEX FOLLOW-UP. THE IMPLANT AND INCIDENT DATES ARE BETWEEN 2005-2006. LITERATURE ARTICLE FROM THE CARDIOVASC. INTERVENT RADIOL. (2007) 30, 182-187).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention