BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4211420 · Received October 29, 2014

    Report

    Report Number
    2953200-2014-02235
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    February 18, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. ELECTIVE ENDOVASCULAR AORTIC REPAIR CONVERSION FOR TYPE IA ENDOLEAK IS NOT ASSOCIATED WITH INCREASED MORBIDITY OR MORTALITY COMPARED WITH PRIMARY JUXTARENAL ANEURYSM REPAIR. SALVATORE T. SCALI, MICHAEL M. MCNALLY, ROBERT J. FEEZOR, CATHERINE K. CHANG, ALYSON L. WATERMAN, SCOTT A. BERCELI, THOMAS S. HUBER, ADAM W. BECK. J VASC SURG 2014;60:286-94. ON UNKNOWN DATES BETWEEN 2002 TO 2012 AN ENDURANT STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: PROXIMAL TYPE I ENDOLEAK, POSTOPERATIVE RUPTURE, DEATH, BLOOD LOSS, INFECTION, CARDIAC AND PULMONARY COMPLICATIONS, RENAL FAILURE, REMOVAL OF IMPLANT. OBJECTIVE: TYPE IA ENDOLEAK AFTER ENDOVASCULAR AORTIC REPAIR (EVAR) CAN BE A CHALLENGING COMPLICATION TO MANAGE, AND DUE TO CONCERNS REGARDING MORBIDITY AND MORTALITY OF OPEN SURGICAL CONVERSION (OSC), REPORTS OF COMPLEX ENDOLUMINAL SALVAGE TECHNIQUES ARE INCREASING. DESPITE DEVELOPMENT OF THESE ENDOVASCULAR REMEDIAL STRATEGIES, MANY PATIENTS ULTIMATELY REQUIRE OSC. THE PURPOSE OF THIS ANALYSIS WAS TO OUTCOMES OF ELECTIVE OSC FOR TYPE IA ENDOLEAK AND COMPARE THEM WITH ELECTIVE PRIMARY OPEN JUXTARENAL ANEURYSM REPAIR (OJAR) TO DETERMINE IF THESE CONCERNS ARE WARRANTED. METHODS: FROM 2000 TO 2012, 54 PATIENTS UNDERWENT EVAR OSC AT MEDIAN TIME OF 27 MONTHS (INTERQUARTILE RANGE, 9-55 MONTHS). INDICATIONS INCLUDED ENDOGRAFT THROMBOSIS IN 2 (4%), INTRAOPERATIVE EVAR FAILURE IN 3 (6%), RUPTURE IN 5 (9%), GRAFT INFECTION IN 6 (11%), AND TYPE IA ENDOLEAK IN 25 (ALL: 38 [70%]). BECAUSE MANY OSCS ARE PERFORMED FOR EMERGENCY INDICATIONS WITHOUT ENDOVASCULAR OPTIONS, WE CHOSE ELECTIVE TYPE IA ENDOLEAK PATIENTS AS OUR STUDY GROUP. THESE 25 PATIENTS WERE COMPARED WITH AN ELECTIVE OJAR COHORT MATCHED BY ANATOMY AND COMORBIDITIES. PRIMARY END POINTS WERE 30-DAY AND 1-YEAR MORTALITY. SECONDARY END POINTS INCLUDED EARLY COMPLICATIONS, CROSS-CLAMP TIME, PROCEDURE TIME, BLOOD LOSS, AND LENGTH OF STAY. RESULTS: DEMOGRAPHIC AND COMORBIDITY DATA IN THE OSC AND OJAR GROUPS DID NOT DIFFER, WITH THE EXCEPTION THAT OJAR PATIENTS PRESENTED WITH SMALLER ANEURYSM DIAMETER AND A HIGHER RATE OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (P [ .03). OSC PATIENTS MORE FREQUENTLY UNDERWENT A NONTUBE GRAFT REPAIR (OSC, N [ 20 [80%] VS OJAR, N [ 6 [24%]; P [.0002), REQUIRED LONGER PROCEDURE TIMES (P [ .03), AND RECEIVED MORE PLASMA TRANSFUSIONS (P [ .03). THE 30-DAY MORTALITY WAS 4% IN BOTH GROUPS (OBSERVED DIFFERENCE IN RATES, 0%; 95% CONFIDENCE INTERVAL FOR DIFFERENCE IN MORTALITY RATES, L14.0% TO 14.0%; P [ 1). A SIMILAR RATE OF MAJOR COMPLICATIONS OCCURRED (OSC, N [ 9 [36%] VS OJAR, N [ 8[32%]; P [ 1). ONE-YEAR SURVIVAL WAS 83% IN OSC AND 91% IN OJAR (OBSERVED DIFFERENCE, 7%; 95% CONFIDENCE INTERVAL, L15% TO 29%; P [ .65). CONCLUSIONS: DESPITE MANY ADVANCES IN EVAR TECHNOLOGY, THE NEED FOR OSC PERSISTS AND WILL LIKELY BECOME MORE COMMON AS OLDER-GENERATION DEVICES FAIL OR PROVIDERS ATTEMPT EVAR IN MORE ANATOMICALLY COMPLEX PATIENTS. ELECTIVE OSC FOR TYPE IA ENDOLEAK CAN BE TECHNICALLY CHALLENGING BUT IS NOT ASSOCIATED WITH INCREASED MORBIDITY OR MORTALITY COMPARED WITH OJAR IN APPROPRIATELY SELECTED PATIENTS. THESE RESULTS SHOULD BE CONSIDERED BEFORE PURSUING COMPLEX ENDOVASCULAR REMEDIATION OF EVAR FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692870 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention