BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4869261 · Received June 25, 2015

    Report

    Report Number
    9612164-2015-01094
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    April 10, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CONCLUSION: (AORTIC NECK ANGULATION, PRE-OPERATIVE RUPTURE, AORTIC NECK LENGTH).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ENDOVASCULAR TREATMENT OF RUPTURED ABDOMINAL AORTIC ANEURYSMS WITH HOSTILE AORTIC NECK ANATOMY. P.P.H.L. BROOS , Y.W. ¿T MANNETJE, PH.W.M. CUYPERS, M.R.H.M. VAN SAMBEEK, J.A.W. TEIJINK. AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF RUPTURED ABDOMINAL AORTIC ANEURYSM REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA ENDOLEAK, OPEN REPAIR, AAA RE-RUPTURE, TYPE IB ENDOLEAK, TYPE III ENDOLEAK, UNINTENTIONAL OVERSIZING OF RENAL ARTERY, OCCLUSION. OBJECTIVE: TO COMPARE THE MID-TERM RESULTS OF ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) FOR RUPTURED ABDOMINAL AORTIC ANEURYSMS (RAAAS) IN PATIENTS WITH FAVOURABLE AORTIC NECK ANATOMY (FNA) AND HOSTILE AORTIC NECK ANATOMY (HNA). METHODS: PATIENTS TREATED FOR A RAAA IN A HIGH VOLUME ENDOVASCULAR CENTRE IN THE NETHERLANDS BETWEEN (B)(6) 2009 AND (B)(6) 2014 WERE IDENTIFIED RETROSPECTIVELY AND DIVIDED INTO TWO GROUPS BASED ON AORTIC NECK ANATOMY, FNA AND HNA. HNA WAS DEFINED AS RAAA WITH A PROXIMAL NECK OF <(><<)>10 MM, OR A PROXIMAL NECK OF 10E15 MM WITH A SUPRARENAL ANGULATION (A) >45_ AND/OR AN INFRARENAL ANGULATION (B) >60_, OR A PROXIMAL NECK OF >15 MM COMBINED WITH A >60_ AND/OR B >75_. PATIENT DEMOGRAPHICS, PROCEDURE DETAILS, 30 DAY AND 1 YEAR OUTCOMES WERE RECORDED. RESULTS: OF 39 INCLUDED PATIENTS, 17 (44%) HAD HNA. TECHNICAL SUCCESS WAS 100% FOR FNA AND 88% FOR HNA (P ¼ .184). THERE WERE NO TYPE IA ENDOLEAKS ON COMPLETION ANGIOGRAPHY IN EITHER GROUP; HOWEVER, MORE ADJUNCTIVE PROCEDURES WERE NECESSARY FOR INTRA-OPERATIVE TYPE IA ENDOLEAKS IN THE HNA GROUP (24% VS. 0%, P ¼ .029). THIRTY DAY MORTALITY RATES WERE COMPARABLE, FNA 14% VS. HNA 12% (P ¼ 1.000). THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES AT 1 YEAR FOLLOW UP IN TYPE I ENDOLEAKS, SECONDARY ENDOVASCULAR PROCEDURES, OR ALL-CAUSE MORTALITY. CONCLUSION: EMERGENCY EVAR PROVIDES EXCELLENT RESULTS FOR TREATMENT OF RAAA PATIENTS WITH BOTH FNA AND HNA. EVAR IN RAAAS WITH HNA IS TECHNICALLY FEASIBLE AND SAFE IN EXPERIENCED ENDOVASCULAR CENTRES. PER THE PHYSICIAN'S STATEMENT, THE REPORTED ADVERSE EVENTS WERE NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412607 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention