BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4141064 · Received October 3, 2014

    Report

    Report Number
    3008011247-2014-00076
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE MID-CROWN OF THE PROXIMAL STENT WAS INADVERTENTLY DEPLOYED PRIOR TO THE RETRACTION OF THE DELIVERY SYSTEM OUTER SHEATH. SIGNIFICANT TENSION AND MANIPULATION OF THE DELIVERY SYSTEM WAS REQUIRED TO UN-SHEATH AND POSITION THE STENT GRAFT. DURING POLYMER FILL, THE FILL POLYMER SYRINGE EMPTIED COMPLETELY AND THE PATIENT EXPERIENCED TRANSIENT HYPOTENSION WHICH WAS SUCCESSFULLY TREATED IN ACCORDANCE WITH THE PRODUCT IFU. THE STENT GRAFT DID NOT FILL WITH POLYMER; CONTRAST WAS INJECTED INTO THE LUMEN OF THE STENT GRAFT TO VISUALIZE THE IPSILATERAL AND CONTRALATERAL LEGS OF THE AORTIC BODY GRAFT TO FACILITATE ACCURATE PLACEMENT OF THE ILIAC LIMBS. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AND THERE WERE NO ADDITIONAL PATIENT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618814 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-D FS042914-35

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention