BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 3002968 · Received March 13, 2013

    Report

    Report Number
    2953200-2013-00442
    Event Type
    Death
    Date Received
    March 13, 2013
    Date of Event
    December 26, 2012
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHODS: (FILMS).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DEATH, CVA/STROKE, OCCLUSION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (BOVINE ARCH, NOT A GOOD TEVAR CANDIDATE). UNAPPROVED USE OF DEVICE (INADEQUATE SEAL ZONE/STENT GRAFT PLACEMENT IN AORTIC ARCH). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (BOVINE ARCH, NOT A GOOD TEVAR CANDIDATE). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (INADEQUATE SEAL ZONE/STENT GRAFT PLACEMENT IN AORTIC ARCH).

    Description of Event or Problem · 1

    REVIEW OF FILMS PRE-IMPLANT SHOW A SEVERELY TORTUOUS AND CALCIFIED THORACIC AORTA. THE THORACIC AORTA IS DILATED IN THE ARCH AND THE 6CM TAA EXTENDS INTO THE DESCENDING THORACIC AORTA. THE THORACIC AORTA IS ACUTELY ANGULATED (APPROXIMATELY 125 DEGREES) AT THE TOP OF THE ARCH, AND THERE ARE TWO 90 DEGREE BENDS BELOW THE ANEURYSM IN THE DESCENDING THORACIC AORTA. THESE TWO BENDS ALSO HAVE THE APPEARANCE OF VESSEL INFOLDING. THE ARCH, THORACIC AORTA NEAR THE GREAT VESSELS, AND DESCENDING THORACIC AORTA ARE SEVERELY CALCIFIED. THE PATIENT ALSO HAD A 5.5CM DIAMETER AAA. IMAGES DURING THE IMPLANT INTO THE ASCENDING THORACIC AORTA WERE NOT PROVIDED. IT IS LIKELY THAT THE TEVAR IMPLANT INTO THE ASCENDING THORACIC AORTA, IN COMBINATION WITH THE CALCIFICATION SEEN THE VESSELS, WAS THE LIKELY CAUSE OF THE STROKE.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 61MM DIAMETER THORACIC AORTIC ANEURYSM APPROXIMATELY 2.5 MONTHS AGO. THE PATIENT HAD A BOVINE ARCH, THE RIGHT AND LEFT COMMON CAROTID ARTERIES APPEARED TO HAVE A COMMON ORIGIN. THE RIGHT SUBCLAVIAN ARTERY APPEARED TO HAVE AN ANOMALOUS ORIGIN AND THIS WAS THE MOST DISTAL OF ALL THE BRANCHES AND THIS APPEARED TO ORIGINATE DIRECTLY FROM THE ANEURYSM SAC. THE LEFT SUBCLAVIAN ARTERY HAD ORIGIN FROM THE AORTA, BUT IT APPEARED TO BE INVOLVED IN THE ANEURYSMAL PROCESS. THE PATIENT ALSO HAD A 4CM DIAMETER AAA THAT THE PHYSICIAN DECIDED TO TREAT CONSERVATIVELY. IT WAS REPORTED THAT THE PATIENT WAS NOT A GOOD CANDIDATE FOR A TEVAR ONLY REPAIR DUE TO AN INADEQUATE SEAL ZONE. THE PHYSICIAN DECIDED TO DO A HYBRID PROCEDURE, PERFORMING A MEDIAN STERNOTOMY UNDER CARDIOPLEGIA BYPASS, DEBRANCH THE GREAT VESSELS TO THE PATIENT'S ARMS AS WELL AS THE NECK, AND THEN COMBINE IT WITH A STENT GRAFT PROCEDURE. MULTIPLE VASCULAR BYPASSES WERE DONE, INCLUDING AORTA TO INTRA-THORACIC RIGHT CAROTID, AORTA TO INTRA-THORACIC GREAT VESSELS LEFT CAROTID, RIGHT CAROTID TO RIGHT SUBCLAVIAN, AND LEFT CAROTID TO LEFT SUBCLAVIAN. FOLLOWING THE BYPASSES, THE FIRST STENT GRAFT WAS IMPLANTED IN THE AORTIC ARCH WITH GOOD PROXIMAL SEAL AND COMPLETE COVERAGE OF THE ARCH VESSELS. TWO ADDITIONAL TWO STENT GRAFTS WERE IMPLANTED TO EXTEND DISTALLY. A RELIANT BALLOON WAS USED TO BALLOON THE PROXIMAL, DISTAL, AND GRAFT-TO-GRAFT JUNCTIONS. FINAL AORTOGRAM SHOWED COMPLETE EXCLUSION OF THE ANEURYSM. THERE WAS EXCELLENT PERFUSION OF THE NEWLY CREATED BYPASS GRAFTS TO THE INNOMINATE ARTERIES AS WELL AS BYPASSES TO THE SUBCLAVIAN ARTERIES. THERE WAS ALSO GOOD PERFUSION OF THE ARTERIES. HEPARIN WAS USED THROUGHOUT THE PROCEDURE, AND PROTAMINE WAS USED FOR COMPLETION OF THE PROCEDURE FOR REVERSAL OF THE HEPARIN. COAGULOPATHY WAS CORRECTED WITH A TRANSFUSION OF BLOOD AND BLOOD PRODUCTS CONSISTING OF FFP AND CRYOPRECIPITATE AS WELL AS PLATELETS. BLOOD WAS ALSO USED FOR ADEQUATE HEMOSTATIS. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE ICU IN CRITICAL BUT STABLE CONDITION. LATER THAT SAME DAY THE PATIENT SUFFERED A CVA AND SUBSEQUENTLY EXPIRED SIX DAYS POST IMPLANT. THE PHYSICIAN BELIEVES THE STROKE WAS CAUSED BY AN EMBOLIS, LIKELY BECAUSE THE SUBCLAVIAN AND CAROTID ARTERIES WERE NOT LIGATED AFTER THEY WERE BYPASSED, AND THAT AREA OF THE THORACIC AORTA HAD LOTS OF PLAQUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106093 VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01695612

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death