BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 4791612 · Received May 22, 2015

    Report

    Report Number
    2953200-2015-00933
    Event Type
    Death
    Date Received
    May 22, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 24, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.0 CM DIAMETER SACCULAR THORACIC ANEURYSM IN MID DESCENDING THORACIC AORTA. A CUT DOWN OF LEFT GROIN WAS PERFORMED. THE 36X36X150 VALIANT CAPTIVA STENT GRAFT WOULD NOT TRACK THROUGH THE CALCIFIED LEFT EXTERNAL ILIAC. THE PHYSICIAN CHOSE TO IMPLANT AN ENDURANT 13X13X82 STENT GRAFT TO REALIGN EXISTING LEFT COMMON ILIAC AORTIC GRAFT AND BALLOON. ALSO PHYSICIAN CHOSE TO EXTEND THE CALCIFIED LEFT EXTERNAL ILIAC ARTERY. ALSO PHYSICIAN CHOSE TO EXTEND THAT GRAFT WITH AN ENDURANT 16X10X124. AFTER BALLOONING, PHYSICIAN CHOSE TO PLACE A 10X38 ICAST COVERED STENT TO ENLARGE LEFT EXTERNAL ILIAC AT A FOCAL STENOSIS. THE VALIANT CAPTIVIA WAS ATTEMPTED TO BE INSERTED AGAIN; HOWEVER, IT WOULD NOT ADVANCE THROUGH THE ICAST STENT, SO PHYSICIAN CHOSE TO EXPOSE THIS AREA THROUGH A RETROPERINEAL CUTDOWN/EXPOSURE. THE VESSEL WERE PAPER THIN AND CALCIFIED, SO PHYSICIAN CHOSE TO EXTEND CURRENT ILIAC COVERED STENTS WITH AN ENDURANT 16X10X156. ONCE THESE WERE IMPLANTED, THE PHYSICIAN CHOSE TO DELIVER THE VALIANT CAPTIVIA STENT GRAFT DIRECTLY THROUGH THE LEFT EXTERNAL ILIAC ARTERY. THE THORACIC GRAFT WAS DELIVERED SUCCESSFULLY TO THE DESCENDING THORACIC ANEURYSM WITHOUT DIFFICULTY. IT WAS REPORTED THAT DURING THE REPAIR TO THE LEFT CALCIFIED EXTERNAL ILIAC, THE PATIENT EXPERIENCED CARDIAC ISSUES AND EXPIRED ON 2015-(B)(6). THE PHYSICIAN DID NOT STATE WHAT THE CAUSE OF THE EVENT WAS. THE PATIENT HAD A PRIOR ENDOGRAFT REPAIR OF ABDOMINAL AORTIC ANEURYSM WITH ANOTHER MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336745 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V06004114

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death| R