BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AUI

    MDR report key: 3734768 · Received April 8, 2014

    Report

    Report Number
    2953200-2014-00677
    Event Type
    Death
    Date Received
    April 8, 2014
    Date of Event
    December 24, 2013
    Report Date
    March 14, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. LONG-TERM RESULTS OF AORTO-UNI-ILIAC STENT GRAFTS FOR THE ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS. JOHN D. DORTCH MD, W. ANDREW OLDENBURG MD, HOUSSAM FARRES MD, BHUPENDRA RAWAL MS, J. MARK MCKINNEY MD, RICARDO PAZ-FUMAGALLI MD, ALBERT G. HAKAIM MD; MAYO CLINIC-JACKSONVILLE, FLORIDA; ANNALS OF VASCULAR SURGERY; 2013, 1915, S0890-5096(14)000071-5. ANEURYSM AT IMPLANT WAS 57 MM IN DIAMETER, AORTIC NECK DIAMETER WAS 27 WITH A LENGTH OF 22 MM. THE CIA WAS 14 MM IN DIAMETER. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE II ENDOLEAK, TYPE I ENDOLEAK, TYPE III ENDOLEAK (JUNCTIONAL) 26 MONTHS POST IMPLANT, RE-INTERVENTION, MIGRATION, DEATH, THROMBOSIS, CONVERSION, PRE-OPERATIVE RUPTURE (ILIAC ARTERY), WOUND COMPLICATIONS, MI, WOUND INFECTION, REMOVAL OF IMPLANT. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVE: LONG-TERM FOLLOW-UP OF PATIENTS WITH AORTOUNI-ILIAC GRAFTS IS LACKING IN THE CURRENT LITERATURE. THE PURPOSE OF THIS STUDY WAS TO REVIEW THE OUTCOMES OF ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) USING COMMERCIALLY AVAILABLE AORTOUNI-ILIAC DEVICES WITH FEMORO-FEMORAL BYPASS IN PATIENTS WHOSE AORTOILIAC ANATOMY WAS UNFAVORABLE FOR BIFURCATED REPAIR. METHODS: A RETROSPECTIVE REVIEW OF 35 PATIENTS FROM SEPTEMBER 2000 TO FEBRUARY 2012, WHO UNDERWENT EVAR WITH COMMERCIALLY MANUFACTURED AORTO-UNI-ILIAC DEVICES. THESE COMPRISED 35/372 (9.4%) OF ALL PATIENTS WHO UNDERWENT EVAR DURING THAT PERIOD. PATIENT RECORDS WERE REVIEWED TO DETERMINE MORBIDITY, MORTALITY, AND SURVIVAL FOLLOWING AORTOUNI-ILIAC REPAIR. PATIENTS WERE FOLLOWED AT 1, 3, 6 AND 12 MONTH INTERVALS WITH CT SCANS DURING EACH VISIT. MEDIAN FOLLOW UP WAS 40 MONTHS (RANGE: 2-135 MONTHS). RESULTS: MEDIAN AGE AT SURGERY WAS 76 YEARS (RANGE: 60 ¿ 93). THE MEDIAN PREOPERATIVE ANEURYSM DIAMETER WAS 57 MM (RANGE: 45 ¿ 71) AND THE MEDIAN POSTOPERATIVE DIAMETER WAS 53 MM (RANGE: 29 ¿ 80). TWO TYPE II ENDOLEAKS OCCURRED ON 1 MONTH CT, WHILE TEN ENDOLEAKS (TYPE I (3), II (6), III (1)) OCCURRED DURING FOLLOW-UP AFTER 1 MONTH. MIGRATION OF THE STENT GRAFT OCCURRED IN 9% (N=3). SECONDARY PROCEDURES WERE REQUIRED IN 26% (N=9) WHILE TERTIARY PROCEDURES WERE REQUIRED IN 3% (N=1). ONE PATIENT REQUIRED TREATMENT FOR THROMBOSIS OF THE ILIAC EXTENSION AND TWO REQUIRED TREATMENT FOR THROMBOSIS OF THE FEM-FEM COMPONENT. MORTALITY OVER THE FOLLOW-UP PERIOD WAS 34% (N=12) WITH NO DEATHS OCCURRING WITHIN 30 DAYS. CONCLUSION: HIGH-RISK PATIENTS WHO PRESENT WITH AORTOILIAC ANATOMY UNSUITABLE FOR BIFURCATED STENT GRAFT PLACEMENT SHOULD BE OFFERED AUI GRAFT PLACEMENT AS A POTENTIAL ALTERNATIVE TO OPEN REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211152 TALENT AUI SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death| R