BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 9594095 · Received January 15, 2020

    Report

    Report Number
    2031527-2020-00013
    Event Type
    Death
    Date Received
    January 15, 2020
    Date of Event
    December 20, 2019
    Report Date
    December 20, 2019
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009013651
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL ASSESSMENT WAS COMPLETED BASED ON THE RECEIVED MEDICAL RECORDS. THE URGENT PRESENTATION WITH RUPTURED AAA AND PATIENT DEATH COMPLAINT WAS CONFIRMED. THE CONTRIBUTING FACTORS FOR THE RUPTURED AAA AND DEATH WAS UNDETERMINED DUE TO A LACK OF THE RELEVANT MEDICAL INFORMATION. IT SHOULD BE NOTED THAT THE PROCEDURE BEFORE THIS WAS AN OFF-LABEL NECK ANATOMY INITIAL CASE AND TREATED A TYPE 1A ENDOLEAK WITH NON-ENDOLOGIX STENTS AND TWO (2) ENDOLOGIX EXTENSIONS (OFF-LABEL - CONCOMITANT USE WITH PRODUCTS OUTSIDE THE IFU). PROCEDURE RELATED HARMS, DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED. 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. 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 CORRECTIONS B1: ADVERSE EVENT/PRODUCT PROBLEM - UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY THE CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX WITH DURAPLY.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AN INFRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) MONTHS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2016 AN INFRARENAL STENT GRAFT EXTENSION, A SUPRARENAL STENT GRAFT EXTENSION AND NON- ENDOLOGIX STENT WERE IMPLANTED TO RESOLVE THIS EVENT. THIS RE-INTERVENTION IS OUTSIDE THE INDICATIONS DUE TO THE USE OF A NON- ENDOLOGIX STENT. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MFR# 2031527-2018-00358. ALSO THE PATIENTS NECK ANATOMY WAS IDENTIFIED TO BE OUTSIDE THE INDICATIONS OF USE (OFF- LABEL) DURING THE INVESTIGATION OF THIS PREVIOUSLY REPORTED EVENT. NOW, APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS PRESENT TO THE EMERGENCY ROOM WITH A RUPTURED AAA DUE TO ANOTHER 1A ENDOLEAK. UNFORTUNATELY THE PATIENT EXPIRED PRIOR TO THE PHYSICIAN PERFORMING AN OPEN REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54880 AFX VELA SUPRARENAL MIH ENDOLOGIX A34-34/C100-O20 V 1252492-011 00818009013651

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death BIFURCATED STENT GRAFT, LOT 1283305023.| LIMB STENT GRAFT, LOT 1252613004.| NON _ ENDOLOGIX STENT.| VELA INFRARENAL, LOT 1252537023.| VELA INFRARENAL, LOT 1252538014.| BIFURCATED STENT GRAFT, LOT 1283305023| LIMB STENT GRAFT, LOT 1252613004| NON _ ENDOLOGIX STENT| VELA INFRARENAL, LOT 1252537023| VELA INFRARENAL, LOT 1252538014