BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4110793 · Received September 23, 2014

    Report

    Report Number
    2031527-2014-00267
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 REMAINS IMPLANTED IN PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. MEDICAL RECORDS AND IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THERE WERE SUBOPTIMAL MEDICAL DOCUMENTATION AND NO IMAGING STUDIES AVAILABLE FOR THIS REVIEW. PRODUCT APPROPRIATENESS AND PATIENT CANDIDACY COULD NOT BE FULLY ASSESSED. CAUTIONARY CONDITIONS FOR PRODUCT USE INCLUDED THE INABILITY TO TOLERATE CONTRASTED EXAMINATIONS DUE TO THE CHRONIC RENAL DISEASE. THE PATIENT'S USE OF ANTICOAGULATION AND ANTIPLATELET THERAPY MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT IN THE FORM OF INCREASED RISK FOR BLEEDING COMPLICATIONS. ALSO, THERE WAS MANIPULATION OF THE SYSTEM (CARDIAC CATHETERIZATION) FIVE MONTHS POST INDEX, WHICH MIGHT HAVE CHANGED THE INTEGRITY OF THE COMPONENTS. THE MEDICAL DOCUMENTATION SUBSTANTIATED THE PRESENCE OF AN ENDOLEAK TYPE I OR II (IMA), AND A TYPE III. NO ANGIOGRAM FINDINGS WERE AVAILABLE, SO AN UNKNOWN ENDOLEAK WAS SUBSTANTIATED. THE SUCCESSFUL SECONDARY PROCEDURE WAS SUBSTANTIATED, AS WAS THE COMPLICATION FOR THE IMMEDIATE RE-ADMISSION FOR RESPIRATORY FAILURE. PALLIATIVE CARE WAS INITIATED FIVE DAYS POST RE-ADMISSION (SEVEN DAYS POST THE EVENT PROCEDURE), AND THEIR EVENTUAL DEATH 16 DAYS POST THE EVENT PROCEDURE WAS ALSO SUBSTANTIATED. THE LOT USAGE HISTORY SHOWED ONE OTHER SIMILAR UNIT WAS INVOLVED, BUT EVENT DID NOT APPEAR TO BE DEVICE RELATED. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. A ROOT CAUSE FOR THE REPORTED ENDOLEAK COULD NOT BE DETERMINED. THERE WERE NO CASE IMAGES PROVIDED THAT MIGHT HAVE HELPED IDENTIFY THE CAUSE OF THE REPORTED UNKNOWN ENDOLEAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 32 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND AN SUPRARENAL AORTIC EXTENSION AN ENDOLEAK WAS REVEALED. REPORTEDLY, INITIALLY IT WAS THOUGHT TO BE A TYPE 3 ENDOLEAK, BUT AFTER WE PLACED THE INFRARENAL AORTIC EXTENSION THERE WAS STILL A SMALL BLUSH. THE PHYSICIAN THOUGHT IT MIGHT BE A TYPE 1 LEAK, SO A GORE CUFF WAS PLACED 1CM SHORT OF THE RENALS AND OVERLAPING THE BRIDGE. AT THAT TIME NO LEAK WAS NOTICED. THERE WAS NO DETERMINATION ON EXACTLY WHERE THE LEAK WAS COMING FROM, AND THE LEAK HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 32 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND AN SUPRARENAL AORTIC EXTENSION AN ENDOLEAK WAS REVEALED. REPORTEDLY, INITIALLY IT WAS THOUGHT TO BE A TYPE 3 ENDOLEAK, BUT AFTER WE PLACED THE INFRARENAL AORTIC EXTENSION THERE WAS STILL A SMALL BLUSH. THE PHYSICIAN THOUGHT IT MIGHT BE A TYPE 1 LEAK, SO A GORE CUFF WAS PLACED 1CM SHORT OF THE RENALS AND OVERLAPING THE BRIDGE. AT THAT TIME NO LEAK WAS NOTICED. THERE WAS NO DETERMINATION ON EXACTLY WHERE THE LEAK WAS COMING FROM, AND THE LEAK HAS BEEN RESOLVED. ADDITIONAL NOTE: THE SUCCESSFUL SECONDARY PROCEDURE WAS SUBSTANTIATED, AS WAS THE COMPLICATION FOR THE IMMEDIATE RE-ADMISSION FOR RESPIRATORY FAILURE. PALLIATIVE CARE WAS INITIATED FIVE DAYS POST RE-ADMISSION (SEVEN DAYS POST THE EVENT PROCEDURE), AND THEIR EVENTUAL DEATH 16 DAYS POST THE EVENT PROCEDURE WAS ALSO SUBSTANTIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590393 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A28-28/C95-O20 W11-4429-008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R