BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX BIFURCATED STENT GRAFT

    MDR report key: 1438258 · Received August 7, 2009

    Report

    Report Number
    2953200-2009-01081
    Event Type
    Death
    Date Received
    August 7, 2009
    Date of Event
    January 1, 2009
    Report Date
    July 10, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (IDENTITY OF DEVICE WITH WHICH PATIENT/CLINICAL OUTCOME NOT PROVIDED), (DEATH, ENDOLEAK, OCCLUSION). CONCLUSIONS: OTHER (IDENTITY OF DEVICE WITH WHICH PATIENT/CLINICAL OUTCOME NOT PROVIDED). (SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    ENDOVASCULAR REPAIR IN THE THORACIC AND ABDOMINAL AORTA: NO INCREASED RISK OF SPINAL CORD ISCHEMIA WHEN BOTH TERRITORIES ARE TREATED HEART INSTITUTE AND HOSPITAL (J ENDOVASC THER 2009; 16: 189-196). TO EVALUATE THE MORBIDITY ASSOCIATED WITH THORACIC AND ABDOMINAL AORTIC REPAIR USING ENDOVASCULAR EXCLUSION ALONE OR COMBINED ENDOVASCULAR AND OPEN REPAIR. BETWEEN 1998 AND 2007, 49 PTS (MEAN) UNDERWENT TREATMENT FOR THORACIC AND ABDOMINAL AORTA DISEASE WITH DESCENDING THORACIC AORTIC (DTA) STENT-GRAFT AND ABDOMINAL AORTIC REPAIR. THIRTY-NINE PTS WITH COEXISTING THORACIC AND ABDOMINAL PATHOLOGIES WERE CLASSIFIED WITH MULTILEVEL AORTIC DISEASE (MLAD), WHEREAS 10 PTS PRESENTED WITH THORACOABDOMINAL ANEURYSM. PTS WERE SEPARATED INTO 3 GROUPS: GROUP 1: THORACIC STENT-GRAFTS AND OPEN ABDOMINAL REPAIR (N=18), GROUP 2: THORACIC AND ABDOMINAL STENT-GRAFTS (N=21), AND GROUP 3: THORACIC STENT-GRAFTS WITH VISCERAL ARTERY DEBRANCHING (N=10). PRIOR CAROTID-SUBCLAVIAN BYPASS WAS PERFORMED IN 3 (6%) PTS WITH A DOMINANT LEFT VERTEBRAL ARTERY. IN 8 (16%) PTS, THE PROCEDURE WAS EMERGENT (4 DISSECTIONS, 3 PENETRATING ULCERS, AND THE AORTOBRONCHIAL FISTULA). FOR TEVAR (GROUPS 1,2 & 3), THE GORE TAG THORACIC ENDOGRAFT WAS USED IN 44 PTS, THE ENDOFIT MODEL IN 4, AND THE TALENT IN 1. THE 21 (43%) ABDOMINAL AORTIC STENT-GRAFTS (GROUP 2) INCLUDED 10 ANEURX, 5 EXCLUDERS (W.L.GORE & ASSOCIATES), 3 ZENITH, 1 POWERLINK, 1 TALENT (MEDTRONIC VASCULAR), AND 1 ENDOFIT. RESULTS: (NOTE THERE IS NO DISTINCTION BETWEEN OUTCOME BY SPECIFIC PRODUCT) THIRTY-DAY MORTALITY WAS 4% (N=2), AND OVERALL MORTALITY WAS 6% (1 LATE) OVER A MEAN 32.9 MONTHS (RANGE 3?58) OF FOLLOW-UP. IN GROUP 1, 1 PT DEVELOPED BOWEL ISCHEMIA AND DIED 2 DAYS LATER. ONE PT IN GROUP 3 DIED ON POSTOPERATIVE DAY 4 RELATED TO ARRHYTHMIA. ONE LATE DEATH IN GROUP 3 OCCURRED AT 3 MONTHS DUE TO AN INFECTED ABDOMINAL GRAFT. FOUR PTS DEVELOPED RENAL FAILURE (2 EACH IN GROUPS 2 AND 3); ONLY 1 PT REQUIRED HEMODIALYSIS. ENDOLEAK OCCURRED IN ONLY 3 (6%) CASES (ALL IN GROUP 2); 1 TYPE I ENDOLEAK WAS REPAIRED WITH A PROXIMAL STENT-GRAFT AND COVERAGE OF THE LSA, 1 TYPE II HAD THE LSA COVERED AND THEN COIL EMBOLIZED, AND A TYPE III ENDOLEAK WAS TREATED WITH AN ADDITIONAL STENT-GRAFT. LIMB ISCHEMIA OCCURRED IN 3 (6%) PTS DURING FOLLOW-UP (1 CASE IN EACH GROUP); THESE WERE TREATED SUCCESSFULLY WITH OPEN THROMBECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX BIFURCATED STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R