BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 5079254 · Received September 15, 2015

    Report

    Report Number
    2031527-2015-00365
    Event Type
    Death
    Date Received
    September 15, 2015
    Date of Event
    August 5, 2015
    Report Date
    October 27, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL ASSESSMENT, THE REPORTED TYPE IIIB ENDOLEAK AND PATIENT DEATH WAS CONFIRMED. A MANUFACTURING RECORD REVIEW WAS PERFORMED, AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATION THAT WOULD EXPLAIN THE REPORTED EVENT. BASED UPON THE INVESTIGATION, A ROOT CAUSE WAS NOT DEFINITELY IDENTIFIED AND THEREFORE, IDENTIFICATION OF A DESIGN OR MANUFACTURING ISSUE IS INCONCLUSIVE. THE CLINICAL REVIEW IDENTIFIED THE FOLLOWING FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT OUTCOME: SEVERE CALCIFICATIONS IN THE BIFURCATION AND ILIAC ARTERIES. ADDITIONAL DEVICES: MODEL A28-28/C75-O20V, SUPRARENAL AORTIC EXTENSION, LOT: 1203049-007, REL. DATE: (B)(6) 2014, EXP. DATE: 12/31/2014. MODEL I20-13/C70F, SA LIMB AORTIC EXTENSION, LOT: 1284771-002, REL. DATE: (B)(6) 2014, EXP. DATE: 10/29/2017. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) 2014 WITH A BIFURCATED AND A VELA SUPRARENAL. SUBSEQUENTLY, A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED A SLIGHT INCREASE IN SIZE AND A VISIBLE ENDOLEAK. IT WAS DETERMINED THE PATIENT HAD A DISTAL ENDOLEAK. THE PHYSICIAN DID AN ANGIO AND PLACED A LIMB STENT GRAFT TO CORRECT THE LEAK. REPORTEDLY, THE PATIENT HAD A ONE MONTH FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY THAT SHOWED AN UNKNOWN ENDOLEAK. THE PHYSICIAN DECIDED TO DO AN EXPLANT OPEN REPAIR TO CORRECT THE LEAK. WHEN THE DOCTOR DID THE EXPLANT HE NOTED A SMALL HOLE IN THE BIFURCATION OF THE MAIN BODY DEVICE. DOCTOR COMPLETED THE PROCEDURE BY REPAIRING IT OPEN. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) 2014 WITH A BIFURCATED AND A SUPRARENAL AORTIC EXTENSION. SUBSEQUENTLY, A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED A SLIGHT INCREASE IN SIZE AND A VISIBLE ENDOLEAK. IT WAS DETERMINED THE PATIENT HAD A DISTAL ENDOLEAK. THE PHYSICIAN DID AN ANGIO AND PLACED A LIMB STENT GRAFT TO CORRECT THE LEAK. REPORTEDLY, THE PATIENT HAD A ONE MONTH FOLLOW UP AND COMPUTED TOMOGRAPHY ANGIOGRAPHY THAT SHOWED AN UNKNOWN ENDOLEAK. THE PHYSICIAN DECIDED TO DO AN EXPLANT OPEN REPAIR TO CORRECT THE LEAK. WHEN THE DOCTOR DID THE EXPLANT HE NOTED A SMALL HOLE IN THE BIFURCATION OF THE MAIN BODY DEVICE. DOCTOR COMPLETED THE PROCEDURE BY REPAIRING IT OPEN. TWO DAYS AFTER EXPLANT, THE PATIENT EXPIRED DUE TO A HEART ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610543 AFX BIFURCATED MIH ENDOLOGIX, INC. BA25-80/I20-40 1101050-018

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R