BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 9924059 · Received April 3, 2020

    Report

    Report Number
    2031527-2020-00127
    Event Type
    Death
    Date Received
    April 3, 2020
    Date of Event
    March 1, 2020
    Report Date
    March 4, 2020
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009010049
    PMA / PMN Number
    P040002
    Removal / Correction Number
    Z-0006-2019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL ASSESSMENT WAS COMPLETED BASED ON THE RECEIVED MEDICAL RECORDS. THE REPORTED TYPE IIIA ENDOLEAK WAS UNCONFIRMED DUE TO A LACK OF RELEVANT MEDICAL IMAGING. THE REPORTED RUPTURE, SURGICAL CONVERSION AND PATIENT DEATH EVENTS WERE CONFIRMED. ALTHOUGH UNCONFIRMED, THE INDEX CASE WAS REPORTED TO BE OFF LABEL (SHORT NECK LENGTH OF 10MM - SHOULD BE EQUAL TO OR GREATER THAN 15MM), NECK TAPER WAS 18.8% (SHOULD BE LESS THAN 10%) WITH A BORDERLINE DISTAL NECK MEASUREMENT OF 31.9MM (SHOULD BE 18-32MM) COULD HAVE CONTRIBUTED TO A TYPE IIIA ENDOLEAK. DEFINITIVE DEVICE AND USER RELATEDNESS FOR THE SAC GROWTH AND RUPTURE COULD NOT BE DETERMINED. THE PROCEDURE RELATED HARMS IDENTIFIED WERE ACUTE RENAL FAILURE, RESPIRATORY FAILURE, HEMODYNAMIC INSTABILITY AND ABNORMAL BLOOD LOSS. THE PATIENT DEATH WAS DETERMINED TO BE DEVICE RELATED. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE WAS NOT RETURNED BY THE HOSPITAL POST EXPLANT; THEREFORE, NO DEVICE 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. B1 ADVERSE EVENT/PRODUCT PROBLEM - UPDATED; E1: NAME AND ADDRESS - EMAIL UPDATED; H6: RESULT CODE ¿ REMOVE 3233; H6: CONCLUSION CODE ¿ REMOVE 11; H10: ADDITIONAL MANUFACTURE NARRATIVE: UPDATED H3 OTHER TEXT : DEVICE NOT RETURNED AFTER EXPLANT.

    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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AAA TO THE EMERGENCY ROOM (ER). A TYPE 3A ENDOLEAK WITH SAC GROWTH WAS IDENTIFIED. THE PHYSICIAN ELECTED TO PERFORM AN OPEN REPAIR AND THE DEVICES WERE EXPLANTED. THE PATIENT WAS REPORTED TO NOT BE IN GOOD HEALTH POST INTERVENTION AND EXPIRED DUE TO POST SURGERY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383080 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX BA28-100/I16-40 1320915-001 00818009010049

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention VELA SUPRARENAL, LOT 1280872019.| VELA SUPRARENAL, LOT 1280872019