BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3852345 · Received June 5, 2014

    Report

    Report Number
    2031527-2014-00157
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    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

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT WAS CONFIRMED BASED ON THE CLINICAL ASSESSMENT IMAGE REVIEW. 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 ALL UNITS WERE 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, A ROOT CAUSE FOR THE REPORTED ENDOLEAK COULD NOT DEFINITELY BE DETERMINED ALTHOUGH THE SEVERE CALCIFICATION, OBSERVED IN THE CLINICAL REVIEW AT THE BIFURCATION, IS CONSIDERED AS A LIKELY FACTOR. THE ANALYSIS OF THE RETURNED DELIVERY SYSTEM DID NOT IDENTIFY A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF TWO BIFURCATED DEVICES AND A SUPRARENAL AORTIC EXTENSION AN ENDOLEAK WAS OBSERVED. THE ENDOLEAK WAS REPAIRED INTRA-OPERATIVELY BY PLACING AN ADDITIONAL BIFURCATED DEVICE WITHIN THE FIRST DEVICE. THE ANATOMY, WHILE NOT TORTUOUS OR CALCIFIED, WAS UNIQUE IN THAT THERE WAS A LARGE DISSECTION AND FALSE LUMEN THAT COMMUNICATED FROM THE THORACIC AORTA TO MID-ABDOMINAL ANEURYSM. AFTER SNARING THE CONTRALATERAL LIMB-WIRE THE MAIN BODY WAS TRANSFERRED INTO THE SHEATH. THE SHEATH AND MAIN BODY WERE THEN ADVANCED TOGETHER UNTIL THE ILIAC LIMBS WERE ABOVE THE ANATOMICAL BIFURCATION; BIFURCATED DEVICE WAS THEN UNSHEATHED, PULLED DOWN ONTO THE BIFURCATION AND DEPLOYED NORMALLY. AFTER ACCURATE PLACEMENT OF THE SUPRARENAL EXTENSION, PIGTAIL WAS RETRACTED AND RE-ADVANCED FOR FINAL ANGIOGRAM. FINAL ANGIOGRAM REVEALED A POSSIBLE TYPE 2 ENDOLEAK WHICH, THROUGH SEVERAL ANGIOGRAMS, WAS DETERMINED TO BE A SIGNIFICANT TYPE 3B IN ADDITION TO A TYPE 2. BILATERAL ANGIOPLASTY BALLOONS WERE PLACED IN BOTH COMMON ILIAC ARTERIES, PIGTAIL WAS PULLED INTO BODY OF AFX GRAFT, AND THE ANGIOGRAM REVEALED A PERSISTENT TYPE 3B, CLARIFYING THE LEAK WAS NOT JUST A TYPE 2. TYPE3B WAS CONFIRMED AND ON THE ANGIOGRAM YOU WILL SEE SOME CONTRAST ESCAPING BEYOND THE BALLOON IN THE LEFT ILIAC AND FILLING THE LEFT HYPO, WHICH APPEARS TO THEN COMMUNICATE WITH THE ANEURYSM. THE APPARENT ENDOLEAK WAS IMMEDIATELY NOTICEABLE UPON COMPLETION ANGIOGRAM; A SECOND BIFURCATED DEVICE WAS PLACED WITHIN THE FIRST ONE, AND THE LEAK APPEARED TO RESOLVE AT THAT TIME. PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328894 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA22-80/I16-40 1069156-012

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention