BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 8106407 · Received November 27, 2018

    Report

    Report Number
    2953200-2018-01630
    Event Type
    Death
    Date Received
    November 27, 2018
    Date of Event
    September 12, 2017
    Report Date
    February 22, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; HYBRID RECONSTRUCTION OF THE AORTIC ARCH: A 15-YEAR FOLLOW-UP CHARLES A. DIETL, MARK LANGSFELD, ADRIANA M. S ANCHEZ AND VON G. SAMEDI, ALBUQUERQUE, NM J THORAC CARDIOVASC SURG 2017;154:E95-7 DOI.ORG/10.1016/J.JTCVS.2017.07.079. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FDC CODED AT INVESTIGATION COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE OFF LABEL ENDOVASCULAR TREATMENT OF A 65MM THORACIC ANEURYSM OF THE DISTAL AORTIC ARCH INVOLVING THE ORIGIN OF THE LEFT SUBCLAVIAN AND LEFT COMMON CAROTID ARTERIES ON AN UNKNOWN DATE. IT WAS REPORTED APPROXIMATELY 12 MONTHS POST THE PROCEDURE A CT SCAN REVEALED A THROMBOSED ANEURYSM SAC AND A TYPE IB ENDOLEAK. THE PATIENT RECEIVED RE-INTERVENTION TO RESOLVE THE ENDOLEAK. 7 YEARS POST THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A CHRONIC CRAWFORD TYPE III THORACOABDOMINAL AORTIC ANEURYSM WITH CHRONIC DISSECTION. RECONSTRUCTION WITH OPEN REPLACEMENT OF SUPRARENAL AORTA COMBINED WITH THORACIC ENDOVASCULAR AORTIC REPAIR WAS PERFORMED. 13 YEARS POST THE INDEX PROCEDURE, THE PATIENT EXPERIENCED SEVERE LEFT SIDED HEADACHES ATTRIBUTED TO SEVERE STENOSIS OF THE LEFT COMMON CAROTID ARTERY GRAFT AND RETROGRADE FLOW WHICH WAS SUSPECTED TO CAUSE AN UNKNOWN ENDOLEAK RESPONSIBLE FOR ANEURYSM ENLARGEMENT. RE-INTERVENTION WITH BYPASS WAS COMPLETED THE EVENT WAS RESOLVED. 15 YEARS POST THE INDEX PROCEDURE, THE PATIENT EXPERIENCED LOWER BACK PAIN AND A NEW MASS HAD DEVELOPED IN HIS LEFT NECK. SUBSEQUENT TESTING REVEALED A DIAGNOSIS OF EPITHELIOID ANGIO-SARCOMA WHICH WAS COMPLICATED WITH PROGRESSIVE RESPIRATORY FAILURE. IT WAS REPORTED THAT THE PATIENT EXPIRED SHORTLY POST DIAGNOSIS. THE CAUSE OF DEATH IS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946535 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death| R