BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 4228335 · Received November 5, 2014

    Report

    Report Number
    2953200-2014-02329
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A JOURNAL ARTICLE: AORTOUNI-ILIAC ENDOGRAFTING AS AN ALTERNATIVE SALVAGE PROCEDURE TO OPEN CONVERSION IN FAILED ENDOVASCULAR ANEURYSM REPAIR ALEXANDER M. PRUSA, MD; ANDREAS G. WIBMER, MD; RICHARD NOLZ, MD; MARIA SCHODER, MD; JOHANNES LAMMER, MD; PETER POLTERAUER, MD, GEORG KRETSCHMER, MD; AND HARALD TEUFELSBAUER, MD J ENDOVASE THER. 2014,21:154-161. ANEURYSM AND VESSEL MORPHOLOGY NOT REPORTED. ON UNKNOWN DATES BETWEEN MARCH 1995 AND JANUARY 2012, UNKNOWN TALENT STENT GRAFTS WERE IMPLANTED. IN SOME CASES, SECONDARY INTERVENTIONS WERE REQUIRED. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA ENDOLEAK, TYPE III SEPARATION, MIGRATION, TYPE IB ENDOLEAK, ANEURYSM ENLARGEMENT, FAILED DELIVERY, INSUFFICIENT EXPANSION, VESSEL INJURY, THROMBOSIS, TYPE IV ENDOLEAK, REMOVAL OF STENT GRAFT, ILIAC ARTERY DISSECTION, STENOSIS, INFECTION, LOWER EXTREMITY ISCHEMIA, ISCHEMIC COLITIS WITH BOWEL NECROSIS. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. PURPOSE: TO PRESENT A SINGLE-CENTER EXPERIENCE WITH FAILED EVAR REQUIRING CONVERSIONS COMPARING OPEN SURGERY TO A MINIMALLY INVASIVE PROCEDURE MODIFYING THE EXISTING STENT GRAFT INTO AN AORTOUNI-ILIAC (AUI) CONFIGURATION. METHODS: A PROSPECTIVELY MAINTAINED DATABASE AT OUR TERTIARY CARE UNIVERSITY HOSPITAL WAS INTERROGATED TO IDENTIFY ALL PATIENTS WITH FAILED EVAR WHO HAD UNDERGONE EITHER STENT-GRAFT MODIFICATION INTO AN AUI CONFIGURATION OR OPEN CONVERSION BETWEEN MARCH 1995 AND JANUARY 2012. PATIENTS WITH LATE ANEURYSM RUPTURES WERE EXCLUDED. THE SEARCH FOUND 30 PATIENTS (ONE HAD INITIAL TREATMENT ELSEWHERE) WHO REQUIRED CONVERSION AMONG THE 688 PATIENTS WHO HAD UNDERGONE EVAR IN THAT TIME PERIOD. BEFORE CONVERSION, 16 (53%) PATIENTS HAD PRIOR ENDOVASCULAR CORRECTIONS TO MAINTAIN ANEURYSM EXCLUSION. RESULTS: AN AVERAGE TIME OF 52.2 MONTHS (MEDIAN 46.9, LQR 0.0-92.5) ELAPSED BETWEEN INITIAL EVAR AND CONVERSION. THERE WERE 11 EARLY CONVERSIONS (INCLUDING 7 ON-TABLE), WHILE 19 PROCEDURES WERE DONE > 30 DAYS POST EVAR. TWENTY-TWO (73%) PATIENTS UNDERWENT AUI ENDOGRAFTING, WHILE OPEN CONVERSIONS WERE CARRIED OUT IN 8 (27%). MEAN HOSPITAL STAY AFTER CONVERSION WAS 19.5 DAYS (MEDIAN 13.0, LQR 8.0-17.0). OVERALL MORTALITY AFTER CONVERSION WAS 3.3% (1 PATIENT AFTER ON-TABLE OPEN CONVERSION), BUT SINCE THE INTRODUCTION OF AUI ENDOGRAFTING AS AN ALTERNATIVE TREATMENT APPROACH, 30-DAY MORTALITY FOLLOWING CONVERSIONS FELL TO ZERO. CONCLUSION: MODIFICATION OF A FAILED STENT-GRAFT INTO AN AUI CONFIGURATION SERVES AS A LESS INVASIVE TREATMENT OPTION COMPARED TO OP EN CONVERSION AND ALLOWS SALVAGE OF THE FAILED DEVICE. WITH THE IMPLEMENTATION OF THIS ALTERNATIVE APPROACH, MORTALITY AFTER CONVERSION PARALLELS THE MORTALITY OF ELECTIVE ABDOMINAL ANEURYSM REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711096 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention