BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3962188 · Received July 28, 2014

    Report

    Report Number
    2031527-2014-00224
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    August 14, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO THE ESTIMATED AORTIC NECK ANGULATION OF GREATER THAN 60 DEGREES AS DEMONSTRATED ON THE PRE-INDEX SIZING SHEET PHOTO. THIS FINDING MIGHT HAVE CONTRIBUTED TO THE SUBSTANTIATED STENT GRAFT COLLAPSE OF THE SUPRARENAL AORTIC CUFF (OPEN CROWN) 1.5 MONTHS POST INDEX. THE CUFF APPEARED TO HAVE REMODELING INTO THE DIAMETER/SHAPE OF THE PRE-IMPLANT AORTIC NECK. THERE WAS NO EVIDENCE OF AN ENDOLEAK OR OBSTRUCTIVE BLOOD FLOW. THE SECONDARY PROCEDURE WAS AND THE INTRA-OPERATIVE INFERIOR STENT MIGRATION WAS SUBSTANTIATED. THE PATIENT WAS DISCHARGED HOME ON POD 2 WITHOUT COMPLICATIONS. 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 SHOWS THAT NO OTHER UNITS FROM THIS LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENTS AT THIS TIME. THE PRODUCT LABELING HAS BEEN REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED STENT COLLAPSE COULD NOT DEFINITELY BE DETERMINED, BUT WAS LIKELY CAUSED BY THE PATIENT ANATOMY, WHICH EXCEEDED THE NECK ANGLE RECOMMENDED IN THE DEVICE INSTRUCTION FOR USE, BEFORE DEVICE DEPLOYMENT. NO PRODUCT DEFICIENCY WAS IDENTIFIED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 1.5 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED THE BIFURCATED STENT GRAFT EXTENDS FROM THE LEVEL OF THE RIGHT RENAL ARTERY ORIGIN ACROSS AN INFRARENAL ABDOMINAL AORTIC ANEURYSM AND INTO THE COMMON ILIAC ARTERIES BILATERALLY. A SHARP KINK WAS OBSERVED IN THE PROXIMAL ASPECT OF THE STENT GRAFT, ABOUT 2.2 CENTIMETERS BELOW ITS ORIGIN; RESULTING IN A SIGNIFICANT HIGH-GRADE STENOSIS AT THE LEVEL OF THIS KINKING IN THE RANGE OF 70-80%. THE EXCLUDED ANEURYSM SAC MEASURES ABOUT 4.3 CENTIMETERS AP BY 4.5 CENTIMETERS TRANSVERSE. THERE IS NO EVIDENCE OF ENDOLEAK. THE ILIAC LIMBS OF THE STENT GRAFT ARE PATENT. THE PHYSICIAN IS MONITORING THE PATIENT AND WILL DETERMINE COURSE OF ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 1.5 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED THE BIFURCATED STENT GRAFT EXTENDS FROM THE LEVEL OF THE RIGHT RENAL ARTERY ORIGIN ACROSS AN INFRARENAL ABDOMINAL AORTIC ANEURYSM AND INTO THE COMMON ILIAC ARTERIES BILATERALLY. A SHARP KINK WAS OBSERVED IN THE PROXIMAL ASPECT OF THE STENT GRAFT, ABOUT 2.2 CENTIMETERS BELOW ITS ORIGIN; RESULTING IN A SIGNIFICANT HIGH-GRADE STENOSIS AT THE LEVEL OF THIS KINKING IN THE RANGE OF 70-80%. THE EXCLUDED ANEURYSM SAC MEASURES ABOUT 4.3 CENTIMETERS AP BY 4.5 CENTIMETERS TRANSVERSE. THERE IS NO EVIDENCE OF ENDOLEAK. THE ILIAC LIMBS OF THE STENT GRAFT ARE PATENT. APPROXIMATELY FIVE MONTHS AFTER FINDING OF KINKING/STENT GRAFT COLLAPSE, THE PHYSICIAN ELECTED TO ADD AN AORTIC EXTENSION TO MITIGATE THE GRAFT COLLAPSE; HOWEVER, DURING THE PROCEDURE AND DUE TO THE SEVERE AORTIC NECK ANGULATION, THE AORTIC EXTENSION SLIPPED DOWN. THE PHYSICIAN IMPLANTED AN ADDITIONAL COMPETITOR STENT WITH GOOD RESULT. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439315 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A25-25/C75-O20 V 1203045-025

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention