BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 2960121 · Received February 13, 2013

    Report

    Report Number
    2031527-2013-00039
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. HOWEVER, OPERATIVE NOTES FROM THE SECONDARY PROCEDURE AND MULTIPLE CT REPORTS WERE REVIEWED BY A CLINICAL REPRESENTATIVE. REVIEW OF THE MANUFACTURING RECORDS AND COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE AND ARE IDENTIFIED IN THE PRODUCT LABELING. BASED ON THE INFORMATION REVIEWED, THE CAUSE FOR THE REPORTED TYPE 1 ENDOLEAK COULD NOT BE DETERMINED.

    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. (B)(4): DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED APPROXIMATELY EIGHT MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND INFRARENAL AORTIC EXTENSION, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED ON A COMPUTED TOMOGRAPHY SCAN. THE PATIENT WAS TREATED WITH A SUPRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY EIGHT MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND INFRARENAL AORTIC EXTENSION, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED ON COMPUTED TOMOGRAPHY SCAN. DURING ATTEMPTED TREATMENT OF THE ENDOLEAK, BY WAY OF SUPRARENAL AORTIC EXTENSION PLACEMENT, THE STENT GRAFT ALLEGEDLY DEPLOYED PREMATURELY FROM THE DELIVERY SYSTEM AND WAS COVERING THE RENAL ARTERIES. IMAGING AND ULTRASOUND REVEALED THAT THE LEFT RENAL WAS PARTIALLY OBSTRUCTED AND THE RIGHT COMPLETELY OBSTRUCTED. THE PHYSICIAN CREATED AN ADDITIONAL ACCESS SITE IN THE BRACHIAL ARTERY IN ORDER TO APPROACH AORTIC CUFF FROM A DESCENDING POSITION. WITH NOTED DIFFICULTY, THE LEFT RENAL ARTERY WAS CANNULATED AND BALLOON DILATATION WAS PERFORMED. THE PHYSICIAN ATTEMPTED TO DEPLOY A BALLOON-EXPANDABLE STENT IN THE LEFT RENAL ARTERY, BUT THE BALLOON BECAME ENTANGLED IN THE AORTIC CUFF UPON RETRACTION AND THE STENT MIGRATED OVER THE WIRE INTO THE THORACIC AORTA REGION. AN AORTIC BALLOON-EXPANDABLE STENT WAS USED TO PIN THE FREE-FLOATING RENAL STENT AGAINST THE AORTIC WALL. NEXT THE RIGHT RENAL WAS ACCESS BY GOING BEHIND THE AORTIC CUFF. A RENAL STENT WAS DEPLOYED IN THE RIGHT RENAL ARTERY, SUCCESSFULLY RESTORING BLOOD FLOW TO THE RIGHT KIDNEY. UROLOGICAL FORCEPS WERE USED IN AN ATTEMPT TO PULL DOWN THE AORTIC CUFF. SOME AMOUNT OF DEFORMATION WAS NOTED ON THE CUFF, BUT REMODELED AFTER THE RIGHT RENAL WAS STENTED. UPON CLOSING THE BRACHIAL ACCESS SITE, THERE WAS NO PULSE IN THE WRIST. THROMBECTOMY WAS SUCCESSFULLY PERFORMED WITH A FOGARTY CATHETER AND PULSE RETURNED TO WRIST. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63130 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A25-25/C75 W11-4920-003

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention