BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 2681586 · Received August 3, 2012

    Report

    Report Number
    2953200-2012-01506
    Event Type
    Death
    Date Received
    August 3, 2012
    Date of Event
    July 9, 2012
    Report Date
    July 11, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (DEATH, PARALYSIS, OCCLUSION, CVA, RENAL FAILURE, EMBOLI), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (EMBOLISM CAUSED FROM COVERAGE OF THE CAROTID ARTERY, MULTI-ORGAN FAILURE), FAILURE TO FOLLOW INSTRUCTIONS (COVERAGE OF THE LCCA). EVALUATION, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (EMBOLISM CAUSED FROM COVERAGE OF THE CAROTID ARTERY, MULTI-ORGAN FAILURE), USER ERROR CONTRIBUTED TO EVENT (COVERAGE OF THE LCCA).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM DIAMETER THORACIC AORTIC ANEURYSM AND DISSECTION APPROXIMATELY FOUR WEEKS AGO. THE PROXIMAL AORTA WAS 41 MM IN DIAMETER AND 17 MM IN LENGTH. THE DISTAL AORTA WAS 34 MM IN DIAMETER. IT WAS REPORTED THAT THE STENT GRAFTS WERE IMPLANTED IN ZONE 1, COVERING THE LEFT COMMON CAROTID AND LEFT SUBCLAVIAN ARTERIES. AN ARCH BYPASS PROCEDURE WAS ALSO PERFORMED. FOLLOWING THE PROCEDURE THE PATIENT DID NOT RECOVER FROM ANAESTHESIA AND THE PHYSICIAN THOUGHT THERE MAY BE A CEREBRAL INFARCTION. THE PATIENT DEVELOPED RENAL FAILURE AND PARAPLEGIA. THE PATIENT'S BLOOD PRESSURE COULD NOT BE CONTROLLED AND THE PATIENT PASSED AWAY. THE PRIMARY CAUSE OF DEATH WAS DUE TO EMBOLISM CAUSED BY CHOLESTEROL AND MULTI ORGAN FAILURE. THE PHYSICIAN COMMENTED THE CAUSE OF THE EMBOLISM WAS RELATED TO THE PROCEDURE, NOT THE DEVICE, SINCE THEY IMPLANTED IN ZONE 1. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01064750

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death