BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9161931 · Received October 7, 2019

    Report

    Report Number
    3008766073-2019-00520
    Event Type
    Injury
    Date Received
    October 7, 2019
    Report Date
    September 20, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CLARIFY THE PATIENTS' AGE FOR BOTH GROUPS AS THERE WAS A DISCREPANCY BETWEEN THE TEXT AND THE TABLE IN THE ARTICLE. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: MINIMAL VERSUS OBLIGATORY DISSECTION OF THE DIAPHRAGMATIC HIATUS DURING MAGNETIC SPHINCTER AUGMENTATION SURGERY. AUTHOR/S: JAMES M. TATUM1, EVAN ALICUBEN1, NIKOLAI BILDZUKEWICZ1, KAMRAN SAMAKAR1, CAITLIN C. HOUGHTON1, JOHN C. LIPHAM1. CITATION: SURGICAL ENDOSCOPY (2019); 33:782¿788. DOI: HTTPS://DOI.ORG/10.1007/S00464-018-6343-5. THE MAGNETIC SPHINCTER AUGMENTATION (MSA) DEVICE WAS INITIALLY IMPLANTED WITH MINIMAL HIATAL DISSECTION (MHD) AT THE DIAPHRAGMATIC HIATUS. DUE TO CONCERN OF POSSIBLE MSA DEVICE DYSFUNCTION IF HERNIATED INTO AN OCCULT OR SMALL HIATAL HERNIA, AND INCREASED UNDERSTANDING TO THE ROLE OF DEFECTIVE CRURA IN REFLUX DISEASE, THE OPERATIVE PROCEDURE WAS CHANGED TO PLANNED OBLIGATORY DISSECTION (OD) OF THE HIATUS AT THE TIME OF ALL IMPLANTATIONS. THIS STUDY INVOLVES 182 PATIENTS WHO UNDERWENT MSA WITH THE LINX REFLUX MANAGEMENT SYSTEM (ETHICON) BETWEEN DECEMBER 2012 AND NOVEMBER 2016 WITH FOLLOW-UP COMPLETE THROUGH NOVEMBER 2017. THE PATIENTS WERE DIVIDED INTO 2 GROUPS: IN MHD GROUP, 96 PATIENTS (50% MALE AND 50% FEMALE; AGE: 63.1±12.0 YEARS; BMI: 26.8±4.3 KG/M2) UNDERWENT MINIMAL HIATAL DISSECTION FROM PERIOD EXTENDED FROM DECEMBER 2012 TO SEPTEMBER 2015 AND IN OD GROUP, 86 PATIENTS (52% MALE AND 48% FEMALE; AGE: 55.3±16.1 YEARS; BMI: 27.8±4.4 KG/M2) UNDERWENT OBLIGATORY DISSECTION FROM PERIOD OF SEPTEMBER 2015 TO 2016. AFTER HIATAL REPAIR WAS COMPLETED, THE EXTERNAL CIRCUMFERENCE OF THE GASTRO-ESOPHAGEAL JUNCTION (GEJ) WAS MEASURED AND AN APPROPRIATELY SIZED LINX DEVICE (ETHICON) WAS PLACED AROUND THE ESOPHAGUS SECURED BY PASSING BETWEEN THE POSTERIOR VAGUS AND THE ESOPHAGEAL WALL. FOR THE MHD GROUP, REPORTED EARLY POST OPERATIVE (< 1 MONTH FROM SURGERY) COMPLICATION INCLUDED SEVERE DYSPHAGIA/DYSPHAGIA (N-67%); LATE POST-OPERATIVE (> 3 MONTHS FROM SURGERY) COMPLICATION INCLUDED RECURRENT GERD/DELAYED ONSET GERD (N-16.3%), AND DELAYED ONSET DYSPHAGIA (N-8.6%); AND LATE COMPLICATION INCLUDED ANY RECURRENT/PERSISTENT HIATAL HERNIA (N-17.1%) IN WHICH 6.6% OF PATIENTS UNDERWENT REPEAT SURGERY FOR HIATAL HERNIA REPAIR +/- LINX REMOVAL. FOR OD GROUP, EARLY POST OPERATIVE (< 1 MONTH FROM SURGERY) COMPLICATION INCLUDED SEVERE DYSPHAGIA/DYSPHAGIA (N-55.3%); LATE POST-OPERATIVE (> 3 MONTHS FROM SURGERY) COMPLICATIONS INCLUDED RECURRENT GERD/DELAYED ONSET GE, AND DELAYED ONSET DYSPHAGIA (N-1.2%); AND LATE COMPLICATIONS INCLUDED ANY RECURRENT/PERSISTENT HIATAL HERNIA (N-6.3%). IN CONCLUSION, OD OF THE HIATUS WITH CRURAL CLOSURE RESULTED IN LESS RECURRENCE OF REFLUX SYMPTOMS AND HIATAL HERNIA, DESPITE AN INCREASED PROPORTION OF PATIENTS WITH LARGER HIATAL HERNIA AND MORE COMPLEX ANATOMIC DISEASE AT THE TIME OF OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954538 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1