BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE/MEDIATED CLOSURE

    MDR report key: 1078369 · Received July 17, 2008

    Report

    Report Number
    2953144-2008-01195
    Event Type
    Injury
    Date Received
    July 17, 2008
    Date of Event
    April 1, 2007
    Report Date
    June 23, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A CASE REPORT NOTED IN AN ARTICLE. NO DEVICE WAS AVAILABLE FOR ANALYSIS. THE PART AND LOT NUMBERS WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ATTACHMENT: HASAN H. DOSLUOGLU, MD, ET AL: "TOTAL PERCUTANEOUS ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS USING PERCLOSE PROGLIDE CLOSURE DEVICES" (J ENDOVASC THER 2007; 14:184-188).

    Description of Event or Problem · 1

    SYMPTOMS/AE: INFECTED PSEUDOANEURYSM REQUIRING DEBRIDEMENT. TIME OF SYMPTOMS: AFTER VESSEL CLOSURE. THE FOLLOWING EVENT WAS NOTED THOUGH A PERIODIC ARTICLE REVIEW. A PATIENT EXPERIENCED AN INFECTED PSEUDOANEURYSM IN THE GROIN FOLLOWING ARTERIOTOMY CLOSURE WITH THE PROSTAR DEVICE. THE PATIENT UNDERWENT TISSUE DEBRIDEMENT AND HAD AN OPEN GROIN WOUND THAT HEALED COMPLETELY WITHOUT ANY FURTHER ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE/MEDIATED CLOSURE MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention