BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 7125493 · Received December 18, 2017

    Report

    Report Number
    2031527-2017-00681
    Event Type
    Death
    Date Received
    December 18, 2017
    Date of Event
    August 10, 2017
    Report Date
    December 12, 2017
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE CLINICAL EVALUATION, BASED ON THE INFORMATION RECEIVED THERE WERE SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING REPORTED EVENTS; RUPTURED AORTIC ANEURYSM, ENDOLEAK TYPE IB FROM THE RIGHT COMMON ILIAC ARTERY(WILL BE REPORTED IN ANOTHER REPORT), ENDOLEAK TYPE IIIB CUFF, AND STENT BUCKLING OF THE MAIN BODY(WAS REPORTED IN REPORT 2031527-2017-00535). CLINICAL EVALUATIONS WAS UNABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING REPORTED EVENTS; INTRAOPERATIVE DEATH. THE MAIN CAUSE OF THE COMPROMISED STENT GRAFT INTEGRITY (STRETCHED AND BREACHED FABRIC) OF THE SUPRARENAL CUFF WAS THE STRATA MATERIAL IN COMBINATION WITH THE MODERATE AORTIC AND LEFT ILIAC TORTUOSITY (ANATOMY-RELATED). THE EARLY, UNRESOLVED MAIN BODY STENT BUCKLING OF THE MAIN BODY STENT, AND OVERCROWDING OF THE INFERIOR STENT MARGIN OF THE CUFF (CAUSED BY AN OVERSIZING OF THE CUFF [OFF LABEL]) WERE EVIDENCE OF INTENTIONAL USER-ERROR. THESE CONDITIONS ALONG WITH THE AORTIC REMODELING AND LOSS OF ADEQUATE OVERLAP ALSO CONTRIBUTED TO THIS EVENT. PROCEDURE-RELATED HARMS COULD BE NOT BE IDENTIFIED DUE TO THE LACK OF MEDICAL INFORMATION SURROUNDING THE REPAIR EVENT. ASSOCIATED CLINICAL HARMS FOR THIS DEVICE MALFUNCTION INCLUDED: SAC GROWTH; TYPE IIIB ENDOLEAK OF THE CUFF; SURGICAL CONVERSION AND INTRAOPERATIVE DEATH. REPORTEDLY, THE PATIENT DID NOT SURVIVE THE SURGERY. A ROOT CAUSE INVESTIGATION WAS CARRIED OUT FOR ALL AFX COMPLAINTS HAVING AN IDENTIFIED FAILURE MODE OF A TYPE IIIB ENDOLEAK. ENDOLOGIX IMPLEMENTED THE FOLLOWING CORRECTIVE ACTIONS WITH THE INTENT OF REDUCING TYPE IIIB ENDOLEAK EVENTS; 1. UPGRADED GRAFT MATERIAL (I.E. DURAPLY) AND 2. UPDATES TO THE IFU AND ADDITIONAL PHYSICIAN TRAINING. THE CHANGE TO DURAPLY GRAFT MATERIAL AND THE IFU CHANGES WERE PUT IN PLACE JULY 2014. THE TYPE IIIB ENDOLEAK RATE FOR AFX MANUFACTURED AND IMPLANTED BEFORE THESE CORRECTIVE ACTIONS WERE PUT IN PLACE IS TRENDING AT (B)(4). SINCE THE CORRECTIVE ACTIONS WERE IMPLEMENTED, THE TYPE IIIB ENDOLEAK EVENTS REPORTED FOR AFX DEVICES HAS BEEN REDUCED TO (B)(4). ROOT CAUSE INVESTIGATION WAS CARRIED OUT FOR ALL AFX COMPLAINTS HAVING AN IDENTIFIED FAILURE MODE OF A TYPE 3B ENDOLEAK. ENDOLOGIX IMPLEMENTED THE FOLLOWING CORRECTIVE ACTIONS WITH THE INTENT OF REDUCING TYPE 3B ENDOLEAK EVENTS; 1. UPGRADED GRAFT MATERIAL (I.E. DURAPLY) AND 2. UPDATES TO THE IFU AND ADDITIONAL PHYSICIAN TRAINING. THE CHANGE TO DURAPLY GRAFT MATERIAL AND THE IFU CHANGES WERE PUT IN PLACE JULY 2014. THE TYPE 3B ENDOLEAK RATE FOR AFX MANUFACTURED AND IMPLANTED BEFORE THESE CORRECTIVE ACTIONS WERE PUT IN PLACE IS TRENDING AT (B)(4). SINCE THE CORRECTIVE ACTIONS WERE IMPLEMENTED, THE TYPE 3B ENDOLEAK EVENTS REPORTED FOR AFX DEVICES HAS BEEN REDUCED TO (B)(4). THE DISTAL LOSS OF SEAL (RIGHT COMMON ILIAC ARTERY) WAS LIKELY CAUSED BY THE OFF-LABEL ILIAC ANATOMY (INTENTIONAL USER-ERROR) AND RETROGRADE FLOW FROM THE RIGHT HYPOGASTRIC ARTERY. ASSOCIATED CLINICAL HARMS INCLUDED: ILIAC SAC GROWTH; AND, A TYPE IB ENDOLEAK. THE REVIEW OF MANUFACTURING LOT CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. DEVICES REMAIN IMPLANTED IN THE PATIENT AND WERE NOT RETURNED, NO EVALUATION COMPLETED. ENDOLOGIX CONTINUES TO INVESTIGATE THIS EVENT AND SIMILAR EVENTS TO ENSURE THE HIGHEST QUALITY AND PATIENT SAFETY.

    Description of Event or Problem · 1

    ON (B)(6) 2017 ENDOLOGIX RECEIVED A MEDWATCH FORM FROM THE IMPLANTING FACILITY STATING THAT A (B)(6) MALE ADMITTED WITH RUPTURED AAA STATUS POST REPAIR IN 2013 WITH AN ENDOLOGIX GRAFT. PATIENT WOULD NOT SURVIVE WITHOUT INTERVENTION AND FAMILY ASKED TO PROCEED WITH AGGRESSIVE MEASURES TO SAVE HIS LIFE. PATIENT DID NOT SURVIVE THE SURGERY. GRAFT REMOVED WITH EVIDENCE OF FAILURE. DURING CLINICAL EVALUATION OF THIS CASE THAT WAS COMPLETED ON (B)(6) 2017, IT WAS DISCOVERED THAT THE PATIENT HAD AN ENDOLEAK TYPE IIIB OF THE SUPRARENAL CUFF(REPORTED IN A SEPARATE REPORT), AND ENDOLEAK TYPE IB OF THE LIMB EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904187 AFX LIMB STENT GRAFT MIH ENDOLOGIX INC. IS20-25/C55 SA 1039937-020

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death