BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3903235 · Received June 30, 2014

    Report

    Report Number
    2953200-2014-01319
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT IN ZONE 4 FOR THE ENDOVASCULAR TREATMENT OF A 62 MM THORACIC AORTIC ANEURYSM. THE DIAMETER OF THE PROXIMAL NECK WAS 32 MM, AND THE LENGTH WAS 113 MM. DURING THE INDEX PROCEDURE, A LUMBAR DRAIN WAS PLACED AND THREE STENT GRAFT COMPONENTS WERE IMPLANTED. A CHIMNEY STENT WAS PLACED IN THE RIGHT RENAL ARTERY AND THE SUPERIOR MESENTERIC ARTERY. THE CELIAC TRUNK AND RIGHT RENAL ARTERY WERE COVERED. NO ADVERSE EVENTS OR DEVICE ISSUES WERE NOTED DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT REMAINED IN THE HOSPITAL FOLLOWING THE PROCEDURE. APPROXIMATELY 2.5 WEEKS POST-IMPLANT, A CT REVEALED EVIDENCE OF BOWEL ISCHEMIA WITH A PERFORATED CECUM AND MASSIVE PNEUMOPERITONEUM. THE CT SCAN SHOWED NO EVIDENCE OF ANOMALIES AT THE LEVEL OF THE STENT GRAFT. THE PATIENT WAS ANEMIC AND DEVELOPED SEPTIC SHOCK NECESSITATING A TRANSFUSION AND LARGE DOSES OF NORADRENALINE. A MEDIAN LAPAROTOMY FOR TOTAL COLECTOMY WAS PERFORMED. DESPITE THESE INTERVENTIONS, THE PATIENT EXPIRED THE SAME DAY. THE PRIMARY CAUSE OF DEATH WAS NOTED TO BE BOWEL ISCHEMIA WITH PNEUMOPERITONEUM AND SHOCK. THE INVESTIGATOR ASSESSED THE BOWEL ISCHEMIA TO BE NOT DEVICE AND NOT PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380091 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04225867

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Death| R