BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 8479943 · Received April 3, 2019

    Report

    Report Number
    2031527-2019-00159
    Event Type
    Death
    Date Received
    April 3, 2019
    Date of Event
    March 7, 2019
    Report Date
    March 7, 2019
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009013552
    PMA / PMN Number
    P040002
    Removal / Correction Number
    Z-0008-2019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE WAS NOT RETURNED AS THE DEVICE REMAINS IMPLANTED THEREFORE NO EVALUATION WAS COMPLETED. A CLINICAL ASSESSMENT OF THE REPORTED EVENT COULD NOT BE COMPLETED DUE TO A LACK OF RECEIPT OF RELEVANT MEDICAL RECORDS AND/OR IMAGING. SEVERAL ATTEMPTS WERE MADE TO OBTAIN MEDICAL RECORDS AND/OR IMAGES BUT NO RESPONSE WAS RECEIVED. AS SUCH, EVENT DETERMINATION, OFF LABEL CONDITIONS, RELATED PATIENT HARMS AND PATIENT DISPOSITION COULD NOT BE INDEPENDENTLY ASSESSED. HOWEVER THE INITIAL PROCEDURE WAS IDENTIFIED AS OUTSIDE THE INDICATIONS FOR USE (OFF-LABEL) DUE TO THE BILATERAL RENAL ARTERY SNORKEL PROCEDURE THIS IS A CONTRIBUTING FACTORS TO THIS EVENT BUT WITHOUT MEDICAL RECORDS AND/OR IMAGES WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS EVENT. NO ADDITIONAL INVESTIGATION OF THIS REPORTED EVENT IS PLANNED HOWEVER IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS COMPLAINT AND SIMILAR COMPLAINTS IN THE EVENT FURTHER INVESTIGATION IS NEEDED. DEVICE ITERATION IS AFX WITH DURAPLY. CORRECTION: RESULT CODE: REMOVE CODE 3221.

    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

    THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE WAS IDENTIFIED AS OUTSIDE THE INDICATIONS FOR USE (OFF-LABEL) DUE TO THE BILATERAL RENAL ARTERY SNORKEL PROCEDURE. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WITH SEPARATION OF THE PROXIMAL AORTIC EXTENSION AND THE BIFURCATED STENT GRAFT AND SAC GROWTH WERE IDENTIFIED. (THIS EVENT WAS PREVIOUSLY REPORT UNDER 2031527-2017-00424). THE PHYSICIAN ELECTED TO IMPLANT TWO (2) INFRARENAL STENT GRAFT EXTENSION TO RESOLVE THIS EVENT. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS REPORTED AS DOING WELL. NOW APPROXIMATELY 1.5 YEARS POST-SECONDARY PROCEDURE THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH A RUPTURED AORTA. ANOTHER 3A ENDOLEAK WITH MULTIPLE DEVICE SEPARATION WERE IDENTIFIED. ANOTHER INTERVENTION WAS PERFORMED. DURING THE PROCEDURE, IT WAS REPORTED THAT IT WAS DIFFICULT TO TRACK A SHEATH, DEPLOY THE INFRARENAL STENT GRAFT AND REMOVE THE DELIVERY SYSTEM DUE TO ANGULATION AND MULTIPLE DEVICE SEPARATIONS. THE PROCEDURE WAS COMPLETED AND AN ANOTHER INFRARENAL STENT GRAFT WAS IMPLANTED. HOWEVER, THE PATIENT CODED AND EXPIRED A SHORT TIME (EXACT AMOUNT OF TIME NOT REPORTED) AFTER THE PROCEDURE. THE EXACT CAUSE OF DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273002 AFX VELA INFRARENAL MIH ENDOLOGIX A34-34/C100V 1591903-015 00818009013552

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death BIFURCATED STENT GRAFT, LOT # 1046713-015| INFRARENAL EXTENSION, LOT 1682838008| SUPRARENAL EXTENSION, LOT 1031798-029| SUPRARENAL EXTENSION, LOT 1041753-031| BIFURCATED STENT GRAFT, LOT # 1046713-015| INFRARENAL EXTENSION, LOT 1682838008| SUPRARENAL EXTENSION, LOT 1031798-029| SUPRARENAL EXTENSION, LOT 1041753-031