BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT STENT GRAFT BALLOON CATHETER

    MDR report key: 1790063 · Received August 6, 2010

    Report

    Report Number
    2953200-2010-01507
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 10, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS: (ARTERIAL TRAUMA/DISSECTION/PERFORATION), (AGGRESSIVE BALLOONING OF ANOTHER MANUFACTURER'S STENT GRAFT WHICH HAD BARBS).

    Description of Event or Problem · 1

    POST IMPLANT OF ANOTHER MANUFACTURER'S STENT GRAFT A RELIANT BALLOON WAS USED AND A RETROGRADE DISSECTION OCCURRED. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT AN AORTIC EXTENDER WAS IMPLANTED IN THE PROXIMAL PORTION OF THE STENT GRAFT. THE PHYSICIAN DECIDED TO MONITOR THE DISSECTION ABOVE SUPRA-RENAL WITH MANAGEMENT OF THE BLOOD PRESSURE WITHOUT ADDITIONAL TREATMENT. FURTHERMORE, IT WAS NOTED ON THE POST OPERATIVE CT THAT THE DISSECTED AREA REACHED THE DISTAL THORACIC AORTIC ARCH. THIS DISSECTION ALSO APPEARED AT THE PROXIMAL END OF THE FALSE LUMEN. IN THE MIDDLE OF THE FALSE LUMEN A CLOT DEVELOPED, BUT IT WAS NOT PRESENT IN THE PROXIMAL AND DISTAL AREAS. THE HOSPITAL ADMISSION WAS EXTENDED TO TAKE A WAIT-AND-SEE APPROACH. THE PATIENT WAS STILL HOSPITALIZED 18 DAYS POST IMPLANT. THE PHYSICIAN COMMENTED THAT THE STENT GRAFT HAS BARBS, AND THIS AREA WAS BALLOONED AGGRESSIVELY WITH THE RELIANT BALLOON AND THIS MAY HAVE BEEN THE CAUSE OF THE DISSECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANT STENT GRAFT BALLOON CATHETER DQY MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention