BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 6298474 · Received February 2, 2017

    Report

    Report Number
    2953200-2017-00143
    Event Type
    Death
    Date Received
    February 2, 2017
    Date of Event
    October 14, 2015
    Report Date
    March 31, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ENLW1624C120EE, SN (B)(4), EXPIRATION DATE: 2014-06-06; ENLW1616C120EE, SN (B)(4), EXPIRATION DATE: 2014-06-06; ENLW1613C120EE, SN (B)(4), EXPIRATION DATE: 2014-06-11. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE UPDATED CRF RECEIVED DOCUMENTED THAT THERE WAS BLEEDING COMPLICATIONS WHICH LED TO THE PATIENT¿S DEATH. THIS EVENT WAS NOT RELATED TO THE DEVICE BUT WAS RELATED TO THE PROCEDURE AND RELATED TO THE ANEURYSM. SECONDARY INTERVENTION WAS REQUIRED (CONVERSION TO OPEN REPAIR AND TRANSFUSION).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR REPEATED FALLS, AND THE PREVIOUSLY REPORTED RETROPERITONEAL HEMATOMA WAS ACCIDENTALLY DISCOVERED DURING PATIENT'S HOSPITALIZATION. A CT SCAN DONE APPROXIMATELY ONE MONTH AFTER THE DISCOVERY OF THE RETROPERITONEAL HEMATOMA SHOWED THAT THE ANEURYSM HAD RUPTURED. THE PATIENT WAS CONVERTED TO OPEN REPAIR DUE TO PATIENT'S POOR GENERAL HEALTH CONDITION. THE PHYSICIAN EXPLANTED THE STENT GRAFTS AND THE AORTO-BI-ILIAC BYPASS GRAFT. THE PATIENT EXPIRED SEVEN DAYS LATER DUE TO MULTI-ORGAN DYSFUNCTION SYNDROME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RUPTURED ANEURYSM WAS AN ANEURYSM OF THE RIGHT COMMON ILIAC ARTERY. INTERVENTION WAS PLANNED PRIOR TO THE RUPTURE BUT WAS CANCELED BECAUSE OF THE PATIENT¿S POOR HEALTH. THE ANEURYSM THEN RUPTURED AND THE PATIENT WAS OPERATED ON AS AN EMERGENCY AND THE PATIENT WAS CONVERTED TO OPEN REPAIR. IT WAS ALSO NOTED THAT A TRANSFUSION WAS REQUIRED. THE INVESTIGATOR ASSESSED THIS TO BE RELATED TO THE PROCEDURE AND THE ANEURYSM. IT WAS ALSO NOTED THAT THIS EVENT RESULTED IN A LIFE-THREATENING INJURY AND HOSPITALIZATION.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF THE PATIENT¿S DEATH IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79674 ENDURANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENBF2516C170EE

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| H| L| R