BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3903041 · Received June 30, 2014

    Report

    Report Number
    2953200-2014-01311
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: (TREATING PRE-OPERATIVE AORTIC RUPTURE).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC AORTA. IT WAS REPORTED THAT A TALENT TAA STENT GRAFT SYSTEM HAD BEEN PREVIOUSLY IMPLANTED IN THE PATIENT. THE DETAILS OF THE TALENT IMPLANT PROCEDURE ARE UNKNOWN, BUT IT WAS CLEAR THAT THE TALENT STENT GRAFT SYSTEM HAD BEEN IN PLACE FOR MORE THAN 30 DAYS. THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED THORACIC AORTA. THE RUPTURE WAS DISTAL TO THE EXISTING TALENT TAA STENT GRAFT. THE PHYSICIAN IMPLANTED TWO VALIANT CAPTIVIA STENT GRAFTS WITH SOME ENDOANCHORS AT THE DISTAL END. THERE WAS NO EVIDENCE OF ENDOLEAK, BUT THE PHYSICIAN USED THE ENDOANCHORS TO GET BETTER APPOSITION OF THE STENT GRAFT TO THE AORTIC WALL. THE FINAL ANGIOGRAM LOOKED GOOD AND THE RUPTURE APPEARED TO BE EXCLUDED. THE PATIENT WAS STABLE AND THE PROCEDURE WAS FINISHED. THE PATIENT SUBSEQUENTLY EXPIRED SHORTLY AFTER BEING TRANSFERRED TO THE ICU. THE CAUSE OF DEATH WAS COMPLICATIONS FROM THE AORTIC RUPTURE. THE PHYSICIAN STATED THAT THE RUPTURE WAS CAUSED BY DISEASE PROGRESSION WITH THE DEVELOPMENT OF A NEW ANEURYSM DISTAL TO THE PREVIOUSLY IMPLANTED TALENT STENT GRAFT, AND THAT THE DEATH WAS NOT RELATED TO THE STENT GRAFTS OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380227 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04176514

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death| R