BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 17247560 · Received July 3, 2023

    Report

    Report Number
    3008766073-2023-00123
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    April 26, 2022
    Report Date
    July 3, 2023
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/3/2023. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC MAGNETIC SPHINCTER AUGMENTATION DEVICE PLACEMENT FOR PATIENTS WITH MEDICALLY-REFRACTORY GASTROESOPHAGEAL REFLUX AFTER SLEEVE GASTRECTOMY AUTHOR(S): SAMIK H. PATEL, BARRY SMITH, ROBERT POLAK, MORGAN POMERANZ, PUNAM V. PATEL, RICHARD ENGLEHARDT CITATION: SURGICAL ENDOSCOPY (2022) 36:8255¿8260; HTTPS://DOI.ORG/10.1007/S00464-022-09261-3 THE AIM OF THIS STUDY IS TO EVALUATE THE EFFICACY OF MAGNETIC SPHINCTER AUGMENTATION (MSA) DEVICE PLACEMENT IN IMPROVING GASTROESOPHAGEAL REFLUX DISEASE (GERD) SYMPTOMS AND REDUCING ANTI-REFLUX MEDICATION USAGE IN PATIENTS WITH PERSISTENT OR DE NOVO GERD AFTER SLEEVE GASTRECTOMY. BETWEEN JANUARY 2018 AND JULY 2020, 22 PATIENTS WHO UNDERWENT LAPAROSCOPIC MSA DEVICE PLACEMENT AFTER SLEEVE GASTRECTOMY WERE INCLUDED IN THE STUDY. THERE WERE 20 FEMALES AND 2 MALES. THE MEAN AGE FOR THE PATIENTS WAS 46 YEARS, WITH RANGE FROM 28 TO 72 YEARS. MEDIAN AGE WAS 47 YEARS. MEAN WEIGHT PRIOR TO MSA DEVICE PLACEMENT WAS 190LBS AND MEAN BMI WAS 32.9 WITH RANGE FROM 25.1 TO 51.9. ALL SLEEVE GASTRECTOMIES WERE PERFORMED LAPAROSCOPICALLY; THE OMENTAL ATTACHMENTS OF THE GREATER CURVATURE OF THE STOMACH WERE TAKEN DOWN WITH AN ENERGY DEVICE (MANUFACTUER: UNKNOWN). A SINGLE BLACK STAPLER LOAD (MANUFACTUER: UNKNOWN) WITHOUT TISSUE REINFORCEMENTS WAS USED TO INITIATE SLEEVE CREATION. PURPLE STAPLER (MANUFACTUER: UNKNOWN) LOADS WERE THEN USED TO CREATE THE REMAINDER OF THE GASTRIC SLEEVE UP TO THE ANGLE OF HIS. FIBRIN SEALANT GLUE (OMRIX, ETHICON) IS APPLIED OVER THE LENGTH OF THE STAPLE LINE FOR FURTHER REINFORCEMENT. THE MSA WAS PERFORMED USING THE LINX REFLUX MANAGEMENT SYSTEM (ETHICON ENDO-SURGERY). CONCOMITANT DIAPHRAGMATIC CRURAL REPAIR WAS PERFORMED IN ALL PATIENTS AT THE TIME OF MSA DEVICE PLACEMENT USING INTERRUPTED SILK SUTURE REPAIR (MANUFACTUER: UNKNOWN). THE REPORTED COMPLICATIONS INCLUDED ONGOING REFLUX WITH SOME ESOPHAGEAL DYSMOTILITY AND SLOW TRANSIT SEEN ON BARIUM SWALLOW STUDY (N=2), MILD DYSPHAGIA (N=2), MILD REFLUX SYMPTOMS (N=2), MILD ESOPHAGEAL STRICTURE WITH PERSISTENT REFLUX AND DYSPHAGIA 6 MONTHS AFTER MSA DEVICE PLACEMENT (N=1), DYSPHAGIA (N=?), AND A 43-YEAR-OLD FEMALE HAD PERSISTENT REFLUX SYMPTOMS (N=1). IN CONCLUSION, MSA DEVICE PLACEMENT IN PATIENTS WITH MEDICALLY REFRACTORY GERD AFTER SLEEVE GASTRECTOMY IS A SAFE AND VIABLE ALTERNATIVE TO ROUX-EN-Y GASTRIC BYPASS WITHOUT CONFERRING ADDITIONAL RISKS. WE SHOW AN IMPROVEMENT IN REFLUX SYMPTOMS AFTER MSA DEVICE PLACEMENT AS EVIDENCED BY DECREASED POST-OPERATIVE GERD-HRQL SCORES, DECREASED ANTI-ACID MEDICATION USAGE, AND OVERALL PATIENT SATISFACTION WITH THE PROCEDURE. FURTHER PROSPECTIVE AND COMPARATIVE STUDIES WITH LONGER TERM FOLLOW-UP ARE NEEDED TO VALIDATE THE USE OF MSA IN PATIENTS WHO HAVE UNDERGONE SLEEVE GASTRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20828 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown