BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4141521 · Received October 4, 2014

    Report

    Report Number
    3008011247-2014-00080
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 15, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Removal / Correction Number
    REPORTED - TBA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS TO CORRECT INFORMATION SUBMITTED IN THE ORIGINAL REPORT WHICH STATED THAT THE PATIENT EXPERIENCED HYPOTENSION. THE PATIENT DID NOT EXPERIENCE HYPOTENSION DURING THE IMPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    BASED UPON THIS EVENT AND AN INCREASE IN COMPLAINTS RELATED TO INCOMPLETE INTRAOPERATIVE POLYMER FILL OF THE OVATION PRIME 29MM AORTIC BODY STENT GRAFT, TRIVASCULAR INITIATED A FIELD SAFETY CORRECTIVE ACTION ON SEPTEMBER 20, 2014 TO RETRIEVE FROM DISTRIBUTOR INVENTORY (B)(4) AFFECTED DEVICES MANUFACTURED WITHIN THE SAME TIME PERIOD AS THE DEVICE FOR THIS EVENT. NO DEVICES IN THE UNITED STATES WERE SUBJECT TO THIS CORRECTIVE ACTION.

    Description of Event or Problem · 1

    A 29MM OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT DURING ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. DURING POLYMER FILL, THE FILL POLYMER SYRINGE EMPTIED AND THE PATIENT EXPERIENCED TRANSIENT HYPOTENSION WHICH WAS SUCCESSFULLY TREATED IN ACCORDANCE WITH THE PRODUCT IFU. THE PHYSICIAN EXPERIENCED DIFFICULTIES CANNULATING THE CONTRALATERAL GATE, WHICH RESULTED IN PROLONGING THE IMPLANT PROCEDURE. A BRACHIAL APPROACH WAS SUCCESSFULLY USED TO CANNULATE THE GATE, DEPLOY THE ILIAC LIMB, AND EXCLUDE THE ANEURYSM WITH NO ADDITIONAL PATIENT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621174 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR STENT GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-D FS031814-17

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention