BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 4191073 · Received October 21, 2014

    Report

    Report Number
    2953200-2014-02142
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    October 16, 2013
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LATE GRAFT EXPLANTS IN ENDOVASCULAR ANEURYSM REPAIR HTTP://DX.DOI.ORG/10.1016/J.JVS.2013.10.079 ON UNKNOWN DATES BETWEEN 1999 AND 2012, UNKNOWN ANEURX, TALENT ABDOMINAL AND ENDURANT STENT GRAFTS WERE IMPLANTED. IN SOME CASES, SECONDARY INTERVENTIONS WERE PERFORMED. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: POST-OP RUPTURE, DEATH, TYPE I, TYPE III, ENDOTENSION (TYPE V), INFECTION, THROMBOSIS/CLAUDICATION, REMOVAL OF IMPLANT, MIGRATION, AORTOENTERIC FISTULA, CARDIAC COMPLICATIONS, PULMONARY COMPLICATIONS, RENAL COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVE: WITH MORE THAN A DECADE OF USE OF ENDOVASCULAR ANEURYSM REPAIR (EVAR), WE EXPECT TO SEE A RISE IN THE NUMBER OF FAILING ENDOGRAFTS. WE REVIEW A SINGLE-CENTER EXPERIENCE WITH EVAR EXPLANTS TO IDENTIFY PATTERNS OF PRESENTATION AND UNDERSTAND OPERATIVE OUTCOMES THAT MAY ALTER CLINICAL MANAGEMENT. METHODS: A RETROSPECTIVE ANALYSIS OF EVARS REQUIRING LATE EXPLANTS, >1 MONTH AFTER IMPLANT, WAS PERFORMED. PATIENT DEMOGRAPHICS, TYPE OF GRAFT, DURATION OF IMPLANT, REASON FOR REMOVAL, OPERATIVE TECHNIQUE, LENGTH OF STAY, COMPLICATIONS, AND IN-HOSPITAL AND LATE MORTALITY WERE REVIEWED. RESULTS: DURING 1999 TO 2012, 100 PATIENTS (91% MEN) REQUIRED EVAR EXPLANT, OF WHICH 61 WERE PLACED AT ANOTHER INSTITUTION. THE AVERAGE AGE WAS 75 YEARS (RANGE, 50-93 YEARS). THE MEDIAN LENGTH OF TIME SINCE IMPLANTATION WAS 41 MONTHS (RANGE, 1-144 MONTHS). EXPLANTED GRAFTS INCLUDED 25 ANEURX (MEDTRONIC, MINNEAPOLIS, MINN), 25 EXCLUDER (W. L. GORE <(>&<)> ASSOCIATES, FLAGSTAFF, ARIZ), 17 ZENITH (COOK MEDICAL, BLOOMINGTON, IND), 15 TALENT (MEDTRONIC), 10 ANCURE (GUIDANT, INDIANAPOLIS, IND), 4 POWERLINK (ENDOLOGIX, IRVINE, CALIF), 1 ENDURANT (MEDTRONIC), 1 QUANTUM LP (CORDIS, MIAMI LAKES, FLA), 1 AORTA UNI ILIAC RUPTURE GRAFT (COOK MEDICAL, BLOOMINGTON, IND), AND 1 HOMEMADE TUBE GRAFT. OVERALL 30-DAY MORTALITY WAS 17%, WITH AN ELECTIVE CASE MORTALITY OF 9.9%, NONELECTIVE CASE MORTALITY OF 37%, AND 56% MORTALITY FOR RUPTURES. ENDOLEAK WAS THE MOST COMMON INDICATION FOR EXPLANT, WITH ONE OR MORE ENDOLEAKS PRESENT IN 82% (TYPE I, 40%; II, 30%; III, 22%; ENDOTENSION, 6%; MULTIPLE, 16%). OTHER REASONS FOR EXPLANT INCLUDED INFECTION (13%), ACUTE THROMBOSIS (4%), AND CLAUDICATION (1%). IN THE FIRST 12 MONTHS, 23 PATIENTS REQUIRED EXPLANTS, WITH TYPE I ENDOLEAK (48%) AND INFECTION (35%) THE MOST FREQUENT INDICATION. CONVERSELY, 22 PATIENTS REQUIRED EXPLANTS AFTER 5 YEARS, WITH TYPE I (36%) AND TYPE III (32%) ENDOLEAK RESPONSIBLE FOR MOST INDICATIONS. CONCLUSIONS: THE RATE OF EVAR LATE EXPLANTS HAS INCREASED DURING THE PAST DECADE AT OUR INSTITUTION. SURVIVAL IS HIGHER WHEN THE EXPLANT IS DONE ELECTIVELY COMPARED WITH EMERGENT REPAIR. DIFFICULTY IN OBTAINING A SEAL AT THE INITIAL EVAR OFTEN LEADS TO FAILURE #1 YEAR, WHEREAS PROGRESSION OF ANEURYSMAL DISEASE IS THE PRIMARY REASON FOR FAILURE >5 YEARS. (J VASC SURG 2014;59:886-93.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670139 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention