BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3265115 · Received August 5, 2013

    Report

    Report Number
    2953200-2013-01502
    Event Type
    Malfunction
    Date Received
    August 5, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (CAUSE OF EVENT IS UNKNOWN); FAILURE TO FOLLOW INSTRUCTIONS (USER INSPECTED DEVICE AND CONTINUED TO USE THE ALLEGEDLY DEFECT DEVICE); UNAPPROVED USE OF DEVICE (PRE-OPERATIVE RUPTURE). CONCLUSIONS: (CAUSE OF EVENT IS UNKNOWN); OFF ¿LABEL, UNAPPROVED OR CONTRAINDICATED USE (PRE-OPERATIVE RUPTURE); FAILURE TO FOLLOW INSTRUCTIONS (USER INSPECTED DEVICE AND CONTINUED TO USE THE ALLEGEDLY DEFECT DEVICE).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM AND SACCULAR THORACIC AORTIC ANEURYSM IN ZONE 0 AND ZONE 3. PRIOR TO THE INDEX PROCEDURE, THE PATIENT HAD AN OPEN STENT FOR AORTIC ARCH REPLACEMENT OF Y SHAPED DEVICE FOR TAA WITH SMA COILING. BYPASS WAS DONE FROM Y SHAPED CIA TO RIGHT/LEFT RENAL ARTERIES. BYPASS WAS DONE FROM RIGHT CIA TO SMA. CELIAC ARTERY WAS EMBOLIZED WITH TEVAR. THERE WAS NO ENDOLEAK AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT WAS BROUGHT IN EMERGENTLY FOUR DAYS LATER WITH A RUPTURED ANEURYSM. WHEN THE 3232200 WAS OPENED, THE BOX STATED IT WAS A 192MM; HOWEVER, IT WAS MEASURED AND FOUND TO BE 178MM WITH RULER FROM ABOVE STERILIZED PACK. THE PHYSICIAN SUCCESSFULLY IMPLANTED THE DEVICE. THE CAUSE OF RUPTURE IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365668 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01100538

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR