BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4090753 · Received September 15, 2014

    Report

    Report Number
    2031527-2014-00282
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. MEDICAL RECORDS AND IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: SIX MONTHS POST INDEX, THERE MIGHT HAVE BEEN EVIDENCE OF COMPONENT REMODELING. THERE APPEARED TO BE A MILD STENT COLLAPSE AT THE BIFURCATION ASSOCIATED WITH IRREGULAR FABRIC BILLOWING OF APPROXIMATELY 1.5 MM, AT THE INFERIOR MARGIN OF THE AORTIC EXTENSION, AT APPROXIMATELY 4.5 CM FROM THE BIFURCATION. IMMEDIATELY ABOVE THIS AREA, THERE APPEARED TO BE AN AREA OF A SMALL VERTICAL STENT SEPARATION WITH NO EVIDENCE OF CONTRAST BREACH. THE ANEURYSM SAC WAS STABLE AT THAT TIME. THIRTY-THREE MONTHS POST INDEX, THE PATIENT PRESENTED URGENTLY WITH A PULSATILE MASS. THERE WAS SUBSTANTIATING EVIDENCE OF: HYPER-DILATED AORTIC EXTENSION WITH STENT FRACTURES; COMPLETE STENT GRAFT SEPARATION; PARTIALLY OCCLUDED STENTS; ENDOLEAK TYPE IIIA; MAIN BODY KINK/COLLAPSE WITH STENT FRACTURES, ENDOLEAK TYPE IIIB AND INTERVAL ANEURYSM SAC GROWTH. THE SECONDARY BRIDGE STENT PROCEDURE WAS SUBSTANTIATED AS WELL AS THE PERSISTENT ENDOLEAK TYPE IA. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED ALL UNITS HAVE BEEN CONSUMED AND NO OTHER UNITS WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT WAS CONFIRMED. THE CLINICAL ASSESSMENT IMAGE REVIEW IDENTIFIED STENT DAMAGE AND ENDOLEAKS. A ROOT CAUSE FOR THE REPORTED ISSUES COULD NOT BE DEFINITELY IDENTIFIED ALTHOUGH THE CLINICAL REVIEW DESCRIBES THE PATIENT'S LONGSTANDING HISTORY OF SEVERE, POORLY CONTROLLED HYPERTENSION THAT MIGHT HAVE CONTRIBUTED TO THE EVENTS ALONG WITH THE POSSIBLE UNRESOLVED ENDOLEAK SIX MONTHS POST PROCEDURE. THE PATIENT IMAGES SHOWED WHAT APPEARS TO BE FRACTURED STENT STRUTS, WITH THE STENTS APPEARING TO HAVE BEEN HEAVILY OVER EXPANDED. BECAUSE THE DEVICES REMAIN IN THE PATIENT, IT COULD NOT BE DETERMINED IF THERE WAS A STRUCTURAL ISSUE WITH THE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 33 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, A CUFF SEPARATION AND WHAT APPEARED TO BE STENT FRACTURES AND STRATA MATERIAL WERE NOTED. REPORTEDLY, THE PATIENT PRESENTED WITH A PULATILE MASS IN THE ABDOMEN. THE PHYSICIAN ELECTED TO RELINE THE MAIN BODY EXTENDING UP WITH AN INFRARENAL AORTIC EXTENSION AND A THORACIC STENT. THERE APPEARED TO BE A PERSISTENT SMALL TYPE 1 ENDOLEAK AT THE END OF THE PROCEDURE. THE PHYSICIAN DOES NOT HAVE PLANS TO PERFORM ANY FURTHER INTERVENTION AT THIS TIME. ADDITIONAL NOTE: THE PATIENT IS NOT AN OPEN REPAIR CANDIDATE. THE PATIENT MEDICAL HISTORY INCLUDES UNCONTROLLED/SEVERE HYPERTENSION 210/110'S; (B)(6)- LOST TO FOLLOW UP AFTER HIS SIX MONTH EXAM - EVERYTHING WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568285 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A28-28/C95-O20 W11-4714-009

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention