BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3130464 · Received May 24, 2013

    Report

    Report Number
    2953200-2013-01004
    Event Type
    Death
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (MYOCARDIAL INFARCTION, DEATH); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; VESSEL SPASMED DURING THE PROCEDURE CAUSING TRAUMA TO THE VESSEL); CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; VESSEL SPASMED DURING THE PROCEDURE CAUSING TRAUMA TO THE VESSEL).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED FOR THE EMERGENT TREATMENT OF AN ENDOVASCULAR TREATMENT OF AN 8 CM IN DIAMETER DESCENDING THORACIC AORTIC ANEURYSM. THE PATIENT HAD A CAROTID ENDARTERECTOMY, AND AN OPEN SURGICAL REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM ON AND UNKNOWN DATE. THE VESSEL MORPHOLOGY WAS REPORTED AS MILD TORTUOSITY, MILD CALCIFICATION, AND SMALL IN DIAMETER ILIAC ARTERIES (7 CM TO 8 CM IN DIAMETER). THERE WAS 2 CM OF LANDING ZONE, WITH A BOVINE ARCH AND THE STENT GRAFT WAS IMPLANTED UP TO THE RIGHT SUBCLAVIAN ARTERY. THE PATIENT PRESENTED WITH SEVERE BACK PAIN. THE CT REVEALED THAT THERE WAS AN 8 CM IN DIAMETER DESCENDING THORACIC AORTIC ANEURYSM. THE FIRST STENT GRAFT WAS IMPLANTED CORRECTLY. IT WAS REPORTED THAT DURING THE ADVANCEMENT OF THE SECOND DEVICE, THERE WAS DIFFICULTIES AND THE DEVICE COULD NOT BE ADVANCED AND WAS REMOVED FROM THE PATIENT; THERE WERE NO KINKS IN THE DEVICE. THE PHYSICIAN WAS AGGRESSIVE ATTEMPTING TO ADVANCE THE STENT GRAFT, INCLUDING PUSHING ON THE ABDOMEN TO MANIPULATE THE AORTA TO ADVANCE THE DELIVERY CATHETER. THE PATIENT¿S BLOOD PRESSURE DROPPED AND IT WAS NOTED THAT THERE WAS EXTRAVASATION IN THE ILIAC ARTERY. THE PHYSICIAN BELIEVES THAT DURING THE ADVANCEMENT OF THE SECOND DEVICE, THE VESSEL SPASMED AND THIS CAUSED THE TRAUMA TO THE VESSEL. A BALLOON WAS ADVANCED ABOVE THE VESSEL TRAUMA FOR BLOOD PRESSURE CONTROL. THE PHYSICIAN ELECTED TO IMPLANT A 16X10X124 ENDURANT TO COVER THE SUSPECTED RUPTURED VESSEL HOWEVER, AFTER THE 16X10X124 ENDURANT WAS IMPLANTED BUT THERE WAS STILL EXTRAVASATION/TYPE I ENDOLEAK. THE STENT GRAFT WAS MODELED WITH A BALLOON BUT THERE WAS STILL EXTRAVASATION. A 16X16X82 ENDURANT STENT GRAFT WAS IMPLANTED PROXIMAL, BUT THE EXTRAVASATION/TYPE I ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN ELECTED TO PARTIALLY OPEN THE PATIENT AND PUT IN A CONDUIT OFF THE AORTA TO STABILIZE THE PATIENT. THE PHYSICIAN THEN SEWED A HEMISHIELD IN THE PATIENT BUT WHEN THE PHYSICIAN ATTEMPTED TO SEW THE HEMISHIELD TO THE PREVIOUS SURGICAL GRAFT IT WAS LIKE PAPER THIN/EGGSHELL. HOWEVER, THE PHYSICIAN WAS ABLE TO SEW THE HEMISHIELD IN THE PATIENT. THE PHYSICIAN PERFORMED A FEMORAL TO FEMORAL BYPASS FROM THE RIGHT. THE PHYSICIAN THAN INSERTED THE 40X36X150 VALIANT STENT GRAFT THROUGH THE CONDUIT AND IMPLANTED THE DEVICE WITHOUT ISSUES. IT WAS REPORTED THE PATIENT HAD AN MI AND EXPIRED LATER THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230834 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01087668

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death| R