BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX STENT GRAFT

    MDR report key: 2437241 · Received February 2, 2012

    Report

    Report Number
    2953200-2012-00226
    Event Type
    Death
    Date Received
    February 2, 2012
    Report Date
    January 8, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNKNOWN. THE EVENT INFORMATION DOES NOT MATCH INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC. RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, RUPTURE, DEATH, MIGRATION). UNKNOWN CAUSE OF EVENT. CONCLUSION: UNKNOWN CAUSE OF EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE, WHICH IS SUMMARIZED AS FOLLOWS: LONG-TERM INFLUENCE OF SUPRARENAL OR INFRARENAL FIXATION ON PROXIMAL NECK DILATATION AND STENTGRAFT MIGRATION AFTER EVAR, DAVID PINTOUX, ANN VASC SURG 2011; 25: 1012-1019 AN ANEURX STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY NOT REPORTED. ON AN UNKNOWN DATE, AN UNKNOWN ANEURX STENT GRAFT WAS IMPLANTED. DURING A RETROSPECTIVE STUDY OF 58 PATIENTS WHO UNDERWENT EVAR BETWEEN (B)(6) 1999 AND (B)(6) 2007 (25 OF WHICH WERE ANEURX), 27 PATIENTS DIED BEFORE THE THEORETICAL 3-YEAR FOLLOW-UP. OF THESE 27, 4 PATIENTS DIED WITHIN 30 DAYS OF IMPLANTATION. TWO LATER DEATHS WERE REPORTED RELATED TO THE ANEURYSM; A SEPTIC RUPTURE AND AN ANEURYSM RUPTURE LINKED TO AN UNKNOWN ENDOLEAK. THERE WERE 6 TYPE I ENDOLEAK REPORTED (2 PROXIMAL, 4 DISTAL), 5 TYPE II ENDOLEAKS REPORTED AND 7 MIGRATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R