BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 6093470 · Received November 10, 2016

    Report

    Report Number
    2953200-2016-01925
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    February 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: "ENDOVASCULAR STENT GRAFT REPAIR OF AORTO-ILIAC PSEUDOANEURYSMS - HOSPITAL KUALA LUMPUR EXPERIENCE." NAN CHUANG KHANG, M SURG, ZAINAL ARIFFIN BIN AZIZI, FRCS (MED J MALAYSIA VOL 71 NO 1 FEBRUARY 2016) ENDURANT OR TALENT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF PSEUDOANEURYSM OF THE THORACIC AORTA, ABDOMINAL AORTA AND ILIAC ARTERIES. IT WAS REPORTED THAT THE PATIENT DEVELOPED A TYPE I ENDOLEAK. THE PATIENT WAS CONVERTED FROM A BIFURCATED STENT GRAFT TO AN AUI WITH AN OCCLUDER. A FEM-FEM BYPASS WAS ALSO PERFORMED. THE PATIENT DEVELOPED ENCEPHALITIS, A RETROPERITONEAL ABSCESS, AND AN AORTO-DUODENAL FISTULA. THE PATIENT EXPIRED 16 MONTHS AFTER THE SECONDARY PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. ABSTRACT BACKGROUND: THIS IS A SINGLE INSTITUTIONAL REVIEW OF AORTOILIAC PSEUDOANEURYSM OF VARIOUS AETIOLOGIES MANAGED WITH ENDOVASCULAR STENT GRAFT REPAIR. METHODS: FROM 2009 TO 2014, 16 PATIENTS HAD ENDOVASCULAR STENT GRAFT INSERTED FOR PSEUDOANEURYSM OF THE THORACIC AORTA, ABDOMINAL AORTA AND ILIAC ARTERIES IN HOSPITAL KUALA LUMPUR. CO-MORBIDITY, CAUSATIVE AGENTS, IN-HOSPITAL MORTALITY, COMPLICATIONS AND OUTCOMES WERE EXAMINED. RESULTS: THE AVERAGE AGE WAS 59.1 YEARS (RANGE 36-77). COMORBIDITIES INCLUDE HYPERTENSION, DIABETES MELLITUS, TUBERCULOSIS, PRIOR INFECTION AND PREVIOUS OPEN ANEURYSMAL REPAIR. ALL PATIENTS HAD RAISED WBC (>10.0X109 /L), ESR OR C-REACTIVE PROTEIN ON ADMISSION WHILE 50% OF PATIENTS HAD FEVER. BLOOD CULTURES WERE POSITIVE IN 4 PATIENTS. ALL PATIENTS WERE GIVEN ANTIBIOTICS. ONLY ONE IN-HOSPITAL MORTALITY WAS NOTED AT DAY-47 POST-PROCEDURE. TWO PATIENTS DIED OF AORTOENTERIC FISTULA AT DISTRICT HOSPITAL EIGHT AND 16 MONTHS LATER. ONE PATIENT DIED OF CHRONIC GRAFT INFECTION TWO YEARS LATER. ONE DIED OF UNRELATED CAUSE. ONE PATIENT DEVELOPED TYPE IB ENDOLEAK FROM INTERNAL ILIAC ARTERY TWO YEARS LATER AND SURGICAL LIGATION WAS PERFORMED. THE AVERAGE FOLLOW UP WAS 15.8 MONTHS. CONCLUSION: ENDOVASCULAR STENT GRAFT REPAIR FOR PSEUDOANEURYSM IS A VIABLE OPTION COMPARED TO OPEN SURGERY. IT IS LESS INVASIVE, HAS LOWER OPERATIVE MORBIDITY AND FAIR OUTCOMES. HOWEVER, SOME CASES MAY BE DUE TO INFLAMMATORY AORTITIS INSTEAD OF INFECTIVE PSEUDOANEURYSM, GIVEN THE FREQUENT CULTURE-NEGATIVE RESULTS. IN ORDER TO OBTAIN HIGH YIELD OF BACTERIA CULTURE FOR INFECTED PSEUDOANEURYSM, OPEN REPAIR WITH TISSUE CULTURE IS STILL THE MAIN MODE OF TREATMENT ESPECIALLY FOR PATIENTS WITH LOW COMORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744289 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death