BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3830343 · Received May 23, 2014

    Report

    Report Number
    2953200-2014-01061
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNAPPROVED OR CONTRAINDICATED USE (STENT GRAFT WAS IMPLANTED IN ZONE 1).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 64X52 MM THORACIC AORTIC ANEURYSM . VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD A THORACIC ANEURYSM ADJACENT TO THE LEFT CAROTID ARTERY. A COMBINED SURGICAL AND TEVAR APPROACH WAS PLANNED. THE PROCEDURE INVOLVED PERFORMING A LEFT SUBLCAVIAN / LEFT CAROTID / RIGHT CAROTID / RIGHT SUBCLAVIAN BYPASS, WITH LIGATION OF THE PROXIMAL LEFT CAROTID (NEAR ORIGIN) AND OCCLUDING OF ORIGIN OF LEFT SUBCLAVIAN ARTERY WITH COILS. A RIGHT FEMORAL ¿ AXILLO BYPASS WAS ALSO DONE TO PROVIDE CEREBRAL FLOW WHILST PLACING THE ENDOVASCULAR COMPONENTS. ANOTHER MANUFACTURER¿S COVERED STENT WAS TO BE USED AS A ¿CHIMNEY¿ CONDUIT INTO THE RIGHT BRACHIO-CEPHALIC. SURGERY BEGAN ON THE BYPASS COMPONENT OF THE PROCEDURE. APPROXIMATELY SEVEN HOURS LATER, THE ENDOVASCULAR COMPONENT BEGAN. A MOBILE IMAGE INTENSIFIER WAS USED FOR ALL IMAGING. A MEASURING ¿PIGTAIL¿ CATHETER WAS PLACED IN THE ASCENDING ARCH FROM THE LEFT AND A ¿DOUBLE CURVED¿¿ LUNDEQUIST WIRE ALSO AROUND THE ARCH FROM THE RIGHT. WITH SOME DIFFICULTY, A 12F SHEATH WAS PLACED FROM THE RIGHT AXILLARY CUTDOWN INTO THE ASCENDING AORTA. THE FIRST MEDTRONIC COMPONENT WAS PLACED AND DEPLOYED. THE DISTAL END WAS APPROXIMATELY 5-6CM FORM THE LEFT SUBCLAVIAN ARTERY ORIGIN. THE PATIENT HAD BEGUN A SLOW DETERIORATION IN CONDITION A FEW HOURS EARLIER. BLOOD TRANSFUSIONS WERE REGULAR AND ONGOING (APPROXIMATELY 8 UNITS GIVEN IN TOTAL) AND BIOCHEMISTRY (EG POTASSIUM, SODIUM LEVELS) WERE RISING, WITH CO2 DROPPING. ARTERIAL MONITORING WAS SHOWING DROPPING PRESSURES WITH TACHYCARDIA. IN THIS ENVIRONMENT, THE FIRST STENT WAS DEPLOYED UNEVENTFULLY. THE SECOND STENT WAS THEN INSERTED AND POSITIONED ACROSS THE ANEURYSM. THE PROXIMAL COMPONENT WAS APPROXIMATELY 3 CM ANTERIOR TO THE RIGHT BRACHIO-CEPHALIC ORIGIN. ANOTHER MANUFACTURER¿S STENT WAS INSERTED AND POSITIONED IN THE ASCENDING ARCH WITH SOME DIFFICULTY AND VISUALIZING THE STENT AND WITH ¿PUSH-BACK¿ OF THE SHEATH. THE SECOND STENT WAS THEN DEPLOYED ACROSS THE ANEURYSM AND AS DESIRED IN POSITION. DEPLOYMENT WAS UNEVENTFUL AND ALTHOUGH AN ATTEMPT WAS MADE TO ¿QUICK DEPLOY¿, THE DEVICE WAS ¿WOUND OUT¿ ALL THE WAY. THE PATIENT ACUTELY DETERIORATED IMMEDIATELY AFTER THIS STENT WAS DEPLOYED AND THE DECISION WAS MADE TO PERFORM CPR. THE OTHER MANUFACTURER¿S STENT WAS QUICKLY DEPLOYED VIA BALLOON INFLATION, THE TABLE LOWERED AND CPR COMMENCED. THE THIRD STENT HAD BEEN OPENED AND PREPPED FOR INSERTION (THE FINAL COMPONENT). HOWEVER, FOLLOWING A CLINICAL DISCUSSION DECISION WAS MADE TO CEASE CPR AFTER APPROXIMATELY 3 MINUTES AND ALL WORK STOPPED. THE PATIENT DIED BEFORE THE THIRD VALIANT COMPONENT WAS INSERTED. THE PHYSICIAN BELIEVES THAT THE PATIENT DEATH IS RELATED TO THE PROCEDURE AND IS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307991 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03041112

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Death| R