BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3864161 · Received June 10, 2014

    Report

    Report Number
    2031527-2014-00172
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    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

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. PRODUCT USE IN THIS COMPLEX AORTO-BI-ILIAC ANEURYSM CASE MIGHT HAVE BEEN CAUTIONARY DUE TO: THE MODERATELY SEVERE CALCIFICATIONS, THE DISSECTED AORTIC, AND MULTIPLE PATENT LUMBAR ARTERIES WITH AN UNUSUALLY LARGE L4 ARTERY. THESE CONDITIONS MIGHT HAVE CONTRIBUTED TO THE PERVASIVE AND PERSISTENT ENDOLEAKS SEEN THROUGHOUT THE COURSE OF THIS IN-VIVO DEVICE. THE PATIENT'S MEDICAL HISTORY MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT IN THE FORM OF ANEURYSMAL DISEASE PROGRESSION. SIXTEEN MONTHS POST INDEX, NO FURTHER CTS WITH CONTRAST WERE PERFORMED DUE TO THE PATIENT'S NEW HISTORY OF CHRONIC RENAL INSUFFICIENCY; THEREFORE, SURVEILLANCE AND THE MONITORING OF ENDOLEAKS WAS GREATLY COMPROMISED. POST TWO SECONDARY PROCEDURES, THE PATIENT'S ANEURYSMAL SACS (AORTA AND RIGHT ILIAC) CONTINUED TO GROW. UNRESOLVED ENDOLEAKS COULD NOT BE DIAGNOSED DUE TO NON-CONTRAST IMAGING. ENDOLEAK OF UNKNOWN ORIGIN WAS SUBSTANTIATED, ALTHOUGH THERE WAS A PREPONDERANCE OF EVIDENCE TO SUPPORT A TYPE II ENDOLEAK IN BOTH THESE AREAS. A CONVERSION AND EXPLANT WERE SUBSTANTIATED. THE DEATH AND A COMPLICATION OF ACUTE RENAL FAILURE WERE NOT REPORTED, BUT WERE SUBSTANTIATED. THERE WAS NO STATED CAUSE OF DEATH, BUT THE PATIENT ON DIALYSIS FOR ACUTE RENAL FAILURE, AND HAD AN ABDOMINAL WOUND INFECTION. THE MANNER OF DEATH (AAGONAL RHYTHM) WASN'T TYPICAL OF HYPOVOLEMIC SHOCK." BASED UPON THE INVESTIGATION FINDINGS, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE PATIENT'S MEDICAL HISTORY AND ANATOMY ARE LIKELY FACTORS. A MANUFACTURING RECORD REVIEW WAS PERFORMED; THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT NO OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 28 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, TWO INFRARENAL AORTIC EXTENSIONS, A SUPRARENAL AORTIC EXTENSION, AND THREE LIMB EXTENSIONS, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL RECURRENT ENDOLEAK AND ANEURYSM GROWTH. THE PHYSICIAN WAS UNCERTAIN WHICH OF THE PROXIMAL COMPONENTS THE LEAK WAS COMING FROM, BUT INDICATED HE COULD RULE OUT IT WASN'T COMING FROM A LUMBAR ARTERY. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND TREATED THE PATIENT WITH A SURGICAL GRAFT. THE PATIENT DID WELL THROUGH OUT THE PROCEDURE AND WAS REPORTED TO BE IN STABLE CONDITION AT THE CONCLUSION OF THE PROCEDURE. ADDITIONAL INFORMATION: THE PATIENT HAD A PRIOR INTERVENTION IN (B)(6) 2013 WHERE AN INFRARENAL AORTIC EXTENSION WAS IMPLANTED TO TREAT AN ENDOLEAK BETWEEN THE PREVIOUSLY IMPLANTED INFRARENAL AORTIC EXTENSION AND THE BIFURCATED DEVICE (2031527-2013-00173).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338433 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A28-28/C75 W11-3116R-016

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention