BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATION ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3010229 · Received March 14, 2013

    Report

    Report Number
    3008011247-2013-00004
    Event Type
    Other
    Date Received
    March 14, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS. BASED ON THE ANALYSIS, THE DEVICE WAS LABELED ON BOTH THE PRODUCT CARTON AND POUCH WITH THE INCORRECT LOT NUMBER AND SIZE (SUBJECT DEVICE FS120910-08 WAS LABELED AS FS081910-08) DURING A RE-LABELING PROCESS TO EXTEND SHELF LIFE. THE DEVICE OVER-LABELED WITH LOT FS120910-08 WAS RETURNED TO TRIVASCULAR. THE PHYSICAL RECEIPT AND EVALUATION OF BOTH DEVICES (LOT FS120910-08 AND FS081910-08) CONFIRMS THAT THE TWO DEVICE LABELS WERE SWITCHED DURING THE RELABELING PROCESS.

    Description of Event or Problem · 1

    SUBJECT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. THE ILIAC LIMB DEVICE (14X14X120MM) WAS REMOVED FROM ITS LABELED PACKAGING. UPON INSERTION OF THE ILIAC LIMB DELIVERY SYSTEM, THE PHYSICIAN NOTED UNDER FLUOROSCOPY THAT THE DEVICE APPEARED SHORTER THAN THE INTENDED SIZE (14X14X120MM). AT THIS TIME, THE TRIVASCULAR CASE SUPPORT VERIFIED THE SIZE ON THE FLUSHPORT BODY OF THE DEVICE TO READ '14MM X 16MM X 100MM'. THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS USED. THERE WERE NO PT SEQUELAE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108363 OVATION ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-IL1414120-B FS081910-08

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention