BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 7251877 · Received February 8, 2018

    Report

    Report Number
    2031527-2018-00070
    Event Type
    Death
    Date Received
    February 8, 2018
    Date of Event
    January 9, 2018
    Report Date
    January 9, 2018
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION RECEIVED AT THE COMPLETION OF THE CLINICAL EVALUATION, CLINICAL WAS UNABLE TO CONFIRM THE PATIENT'S URGENT PRESENTATION OF A TYPE II ENDOLEAK, RUPTURE, COAGULOPATHY, GIT BLEED, BLOOD TRANSFUSION, AND DEATH. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO DEVICE RELATED ISSUE RATHER, IT WAS REPORTED PATIENT HAD TYPE II ENDOLEAK WHICH WAS BEING MONITORED AND IT RUPTURED. URGENT PRESENTATION, RUPTURE, BLOOD TRANSFUSION AND DEATH COULD NOT BE DETERMINED DUE TO THE LACK OF MEDICAL INFORMATION. REPORTEDLY, THE PATIENT REFUSED TREATMENT FOR THE RUPTURE AND EXPIRED THREE DAYS LATER. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AFTER EXPIRATION, AND WERE NOT RETURNED. NO DEVICE EVALUATION WILL BE COMPLETED. A REVIEW OF THE MANUFACTURING LOT CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THESE TYPES OF EVENTS WILL BE MONITORED AND TRENDED AS PART OF THE QUALITY SYSTEM.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INITIAL IMPLANT HAPPENED IN (B)(6) 2017. THE PHYSICIAN REPORTS THAT THE PATIENT WAS BEING FOLLOW FOR A TYPE II ENDOLEAK. THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AAA AND EXPIRED THREE DAYS POST RUPTURE. PHYSICIAN BELIEVES THE CAUSE OF THE RUPTURE IS RETROGRADE TYPE II ENDOLEAK AND AT THE TIME OF THE EVENT THE PATIENT WAS ALSO BEING TRANSFUSED FOR GIT BLEED AND HAD VERY LOW PLATELETS AND FIBRINOGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98493 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX INC. BA25-100/I16-40 1342406008

    Patients

    Seq Age Sex Outcome Treatment
    1 Death INFRARENAL EXTENSION, LOT 1621209006| LIMB STENT GRAFT, LOT 1597968011| LIMB STENT GRAFT, LOT 1680193001| SUPRARENAL EXTENSION, LOT 1484357009