BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3103283 · Received May 9, 2013

    Report

    Report Number
    2953200-2013-00871
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INCORRECT TECHNIQUE/PROCEDURE (USE OF A DEFECTIVE DEVICE). CONCLUSIONS: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (USE OF A DEFECTIVE DEVICE).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS NOT A FACTOR IN THIS EVENT. IT WAS REPORTED THAT PRIOR TO USE WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE AND IT WAS IMMEDIATELY NOTICED THAT THE SIDE FLUSH PORT HAD BROKEN OFF. IT WAS NOT ABLE TO BE REPAIRED. THE PHYSICIAN WAS UNABLE TO FLUSH THE OUTER GRAFT COVER WITH HEPARIN SALINE WITH THE USE OF A 20G NEEDLE. THE PHYSICIAN INSERTED AN ANGIO-CATHETER (PLASTIC NEEDLE) INTO THE SIDE PORT TO FLUSH, WHICH WORKED FOR FLUSHING THE DEVICE. THE PHYSICIAN CONTINUED TO PREP THE DEVICE WITHOUT ISSUE. THE STENT GRAFT WAS IMPLANTED WITHOUT ISSUE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED; THE SIDE PORT EXTENSION WAS DISCONNECTED FROM THE DELIVERY SYSTEM. THE BARB ADAPTOR SNAPPED FLUSH WITH THE SCREWGEAR HOLE. EVALUATION OF THE DEVICE COULD NOT CONCLUSIVELY DETERMINE A ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203469 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00992059

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR