BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3658221 · Received March 4, 2014

    Report

    Report Number
    2953200-2014-00385
    Event Type
    Death
    Date Received
    March 4, 2014
    Date of Event
    October 1, 2013
    Report Date
    February 14, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAKS, MIGRATION, OCCLUSION, WOUND COMPLICATIONS, STENOSIS, ENDOTENSION, COLONIC ISCHEMIA, INCISIONAL HERNIA, INTESTINAL OBSTRUCTION, GRAFT INFECTION, EMBOLIC PHENOMENA, ANEURYSM RUPTURE, BLEEDING, AND DEATH); (UNKNOWN CAUSE OF EVENTS); CONCLUSION: (UNKNOWN CAUSE OF EVENTS).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE: REINTERVENTION AFTER EVAR AND OPEN SURGICAL REPAIR OF AAA A 15-YEAR EXPERIENCE. MUSTAFA AL-JUBOURI, MD, ANTHONY J. COMEROTA, MD, SUBHASH THAKUR, MD, FAISAL AZIZ, MD, STEVEN WANJIKU, MSC, DAVID PAOLINI, MD, JOHN P. PIGOTT, MD, AND FEDOR LURIE, MD, PHD. ANN SURG 2013;258:652¿658 THE REPORTED EVENTS REQUIRING EITHER EMERGENT OR ELECTIVE INTERVENTION ARE: ENDOLEAKS, (TYPE I, TYPE II, TYPE, TYPE III, TYPE IV AND TYPE V) MIGRATION, OCCLUSION, WOUND COMPLICATIONS, STENOSIS, ENDOTENSION, COLONIC ISCHEMIA, INCISIONAL HERNIA, INTESTINAL OBSTRUCTION, GRAFT INFECTION, EMBOLIC PHENOMENA, ANEURYSM RUPTURE, BLEEDING, AND DEATH. OBJECTIVE: THIS STUDY EXAMINED THE FREQUENCY AND REASON FOR REINTERVENTIONS AND THEIR IMPACT ON SURVIVAL IN CONTEMPORANEOUSLY TREATED COHORTS OF EVAR AND OPEN SURGICAL REPAIR (OSR) PATIENTS. BACKGROUND: EVAR HAS LARGELY REPLACED OSR FOR ANATOMICALLY APPROPRIATE AAA BECAUSE OF IMPROVED SHORT-TERM OUTCOMES. HOWEVER, EVAR IS ASSOCIATED WITH A NOTABLE REINTERVENTION RATE. METHODS: DATA FOR PATIENTS UNDERGOING ELECTIVE AAA REPAIR BETWEEN 1996 AND 2011 WERE COLLECTED AND ANALYZED TO ASSESS TIME FROM INITIAL PROCEDURE TO REINTERVENTION AND RATE OF REINTERVENTION. PATIENT DEMOGRAPHICS, COMORBIDITIES, NUMBER AND TYPE OF REINTERVENTIONS, GRAFT TYPE, AND TIMING OF REINTERVENTION WERE ANALYZED. RESULTS: A TOTAL OF 1144 PATIENTS UNDERWENT AAA REPAIR; 558 HAD EVAR AND 586 HAD OSR. IN 76 EVAR PATIENTS, 123 REINTERVENTIONS WERE PERFORMED; 46 REINTERVENTIONS WERE PERFORMED IN 30 OSR PATIENTS (P <(><<)> 0.0001). ENDOLEAK WAS RESPONSIBLE FOR 66% OF EVAR REINTERVENTIONS; COLONIC ISCHEMIA, BLEEDING, AND INCISIONAL HERNIAS CAUSED 30%, 22%, AND 22% OF OSR REINTERVENTIONS, RESPECTIVELY. TIME TO FIRST REINTERVENTION WAS SHORTER IN OSR PATIENTS (P <(><<)> 0.001) AND WAS RELATED TO AAA SIZE (P <(><<)> 0.001). EARLY REINTERVENTION AT THE INDEX PROCEDURE IN OSR PATIENTS HAD A 23% MORTALITY RATE. IF REINTERVENTIONS WERE NOT REQUIRED, SURVIVAL CURVES WERE SIMILAR. CURRENT ENDOGRAFTS REQUIRE FEWER REINTERVENTIONS THAN EARLIER GENERATION ENDOGRAFTS. CONCLUSIONS: REINTERVENTION WAS MORE COMMON WITH EVAR AND OCCURRED LATER. EARLY REINTERVENTION AFTER OSR IS ASSOCIATED WITH SIGNIFICANT MORTALITY. IF EARLY REINTERVENTION IN OSR PATIENTS CAN BE AVOIDED, THERE IS NO EARLY SURVIVAL ADVANTAGE TO EVAR. CURRENT ENDOGRAFTS REQUIRE FEWER REINTERVENTIONS THAN EARLIER DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130187 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| R