BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T LINX, 17 BEADS

    MDR report key: 9305056 · Received November 11, 2019

    Report

    Report Number
    3008766073-2019-00533
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    October 24, 2019
    Report Date
    October 17, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005370
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 01/08/2020. DEVICE ANALYSIS: THE VISUAL ANALYSIS WAS CONSISTENT WITH AN EXPLANTED DEVICE, AND LINK LENGTH AND TENSILE FORCE WERE FOUND TO MEET THE APPLICABLE SPECIFICATIONS. THE REMAINING DEVICE CHARACTERISTICS SHOW NO ANOMALIES FOR A DEVICE THAT HAS BEEN REASONABLY CHANGED AS PART OF THE EXPLANT PROCEDURE. ANALYSIS FOUND THAT THE RETURNED DEVICE HAD AN EXPOSED WELD BALL VISIBLE PAIRED WITH THE WASHER SIDE OF THE ADJACENT BEAD. THE SMALLEST WASHER THROUGH-HOLE DIAMETER WAS MEASURED WITH COMPUTED TOMOGRAPHY (CT) AND WAS FOUND TO BE OUT OF SPECIFICATION. IT WAS NOTED THAT THE WASHER THROUGH-HOLE WAS NOT CONCENTRIC AND HAD A CONICAL SHAPE TAPERING IN DIAMETER TOWARDS THE OUTSIDE OF THE THROUGH-HOLE. THIS IRREGULARITY IN THE SHAPE OF THE THROUGH-HOLE COULD BE DUE TO THE MANUFACTURING PROCESS OR FORCES APPLIED DURING THE IMPLANT & EXPLANT PROCEDURES OR IN VIVO WEAR OR A COMBINATION OF FACTORS. OVERALL, VISUAL ANALYSIS OF THE WASHER SEEMS TO SUGGEST THAT THESE IRREGULARITIES DID NOT CONTRIBUTE TO THE OUT-OF-SPECIFICATION THROUGH-HOLE DIAMETER. THE PAIRED WELD BALL DIAMETER WAS FOUND TO MEET SPECIFICATIONS. IT WAS NOTED THAT THE WELD BALL WAS OFF-CENTERED IN LATERAL VIEW. THE WELD-BALL DIAMETER IN LATERAL VIEW WAS MEASURED. THERE IS NO SPECIFICATION FOR A WELD BALL IN LATERAL VIEW. AS THE DEVICE WAS TESTED TO 250G TENSILE FORCE IN PRODUCTION, IT IS PRESUMED THAT A CERTAIN GEOMETRIC COMBINATION OF THE WELD BALL AND THE WASHER HOLE RESULTED IN THE DEVICE SEPARATION IN VIVO.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/04/2019.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 11/11/2019. PER PHOTOGRAPHIC EVALUATION: THE DEVICE DOESN'T SEEM TO HAVE THE EXPECTED ANNULAR SHAPE IN THE X-RAY IMAGES. THE "C" SHAPE OF THE DEVICE SEEMS CONSISTENT WITH A DISCONTINUOUS DEVICE. THE MECHANISM/CAUSE OF FAILURE CANNOT BE DETERMINED FROM THE PROVIDED IMAGES. THE DHR FOR LOT 8843 WAS REVIEWED. NO DEFECTS, NCRS, OR REWORKS RELATED TO THE PRODUCT COMPLAINT WERE FOUND. LOT 8843 WAS AN AFFECTED LOT OF THE 2018 LINX RECALL. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT SYMPTOMS LEAD TO THE DISCOVERY OF THE DISCONTINUOUS DEVICE? ACID REFLUX. WHEN DID THEY BEGIN? SUMMER 2019. WHAT WAS THE DATE OF THE IMAGING WHICH SHOWED THE DISCONTINUOUS LINX? (B)(6) 2019. WAS THE DEVICE INITIALLY EFFECTIVE IN CONTROLLING REFLUX? YES. WERE ANY EVENTS ASSOCIATED WITH THE ONSET OF SYMPTOMS (VOMITING, RETCHING, TRAUMA, SURGERY)? NOT THAT WE ARE AWARE OF. DID THE PATIENT UNDERGO AN MRI SINCE DEVICE IMPLANT? NO. DID THE PATIENT HAVE ANY OTHER SURGERIES IN THE AREA? PREVIOUS NISSEN AND HIATAL HERNIA REPAIR AT DIFFERENT FACILITY APPROXIMATELY, 2015. WAS ANY ADDITIONAL IMAGING PERFORMED SINCE DEVICE IMPLANT? DOES THE DEVICE APPEAR TO BE IN A CONTINUOUS ANNULAR STATE IN THESE IMAGES? WE ARE INTERESTED IN ESTABLISHING A WINDOW WHEN THE DEVICE MAY HAVE BECOME DISCONTINUOUS. PLEASE SHARE ANY ADDITIONAL IMAGES. NO ADDITIONAL IMAGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT TO A LINX REFLUX MANAGEMENT DEVICE, PATIENT HAD RTO WITH GERD SX 9/19, X-RAY ESOPHAGRAM SHOWS DEVICE SEPARATING UPON BOLUS. PATIENT HAD NISSEN/HHR 3-4 YRS AGO BY ANOTHER SURGEON, NISSEN TAKE DOWN, HHR AND LINX (B)(6) 2016. ON (B)(6) 2019 DISCONTINUOUS LINX WAS REMOVED, HHR AND RNY DONE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097723 1.5T LINX, 17 BEADS ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. 8843 00855106005370

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR