BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9146693 · Received October 2, 2019

    Report

    Report Number
    3008766073-2019-00505
    Event Type
    Injury
    Date Received
    October 2, 2019
    Report Date
    September 19, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A COMPARATIVE TRIAL OF LAPAROSCOPIC MAGNETIC SPHINCTER AUGMENTATION AND NISSEN FUNDOPLICATION. AUTHOR/S: ERIC G. SHEU, PETER NAU, BARBARA NATH, BRADEN KUO, DAVID W. RATTNER. CITATION: SURG ENDOSC. 2015; 29: 505¿509. DOI: 10.1007/S00464-014-3704-6. LAPAROSCOPIC MAGNETIC SPHINCTER AUGMENTATION (MSA) WITH THE LINX DEVICE IS A PROMISING NEW THERAPY FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD). INITIAL STUDIES HAVE DEMONSTRATED MSA TO BE SAFE AND EFFECTIVE. HOWEVER, NO DIRECT COMPARISON BETWEEN MSA AND LAPAROSCOPIC NISSEN FUNDOPLICATION (LNF), THE GOLD STANDARD SURGICAL THERAPY FOR GERD, HAS BEEN PERFORMED. A SINGLE INSTITUTION, CASE-CONTROL STUDY WAS CONDUCTED OF MSA (AGE: 39.3 ± 12.9; 41.7 FEMALE; BMI: 26.8 ± 4.4) PERFORMED FROM 2012 TO 2013 AND A CASE-MATCHED COHORT OF LNF (AGE: 43.8 ± 9.2; 50 FEMALE PATIENTS; BMI: 26.8 ± 3.6) DURING THE SAME TIME PERIOD. IN THE MSA GROUP, THE POSTERIOR VAGUS WAS IDENTIFIED, A WINDOW WAS CREATED BETWEEN THE POSTERIOR VAGUS AND ESOPHAGUS, AND THIS SPACE WAS MARKED WITH A VESSEL LOOP. THE LINX DEVICE (ETHICON) WAS SIZED ACCORDING TO THE MANUFACTURER¿S INSTRUCTIONS, AND THE DEVICE WAS SUBSEQUENTLY PLACED TO ENCIRCLE THE ESOPHAGUS AT THE GE JUNCTION, EXCLUDING THE POSTERIOR VAGUS, AND SECURED WITH THE TI-KNOT DEVICE. IN THE LNF GROUP, A COMPLETE CRURAL DISSECTION TO MOBILIZE >3 CM INTRA-ABDOMINAL ESOPHAGUS WAS PERFORMED. THE SHORT GASTRIC VESSELS SUPPLYING THE FUNDUS WERE DIVIDED, AND A 360 FLOPPY FUNDOPLICATION WAS FASHIONED OVER A 56F BOUGIE USING THREE PLEDGETED ETHIBOND SUTURES (ETHICON), EACH INCORPORATING ESOPHAGEAL WALL. A POSTERIOR CRURAL REPAIR WAS PERFORMED WITH PLEDGETED ETHIBOND 0 SUTURES (ETHICON). IN THE MSA GROUP, REPORTED COMPLICATIONS INCLUDED ANY DYSPHAGIA (83%), DYSPHAGIA (50%) WHICH REQUIRES ENDOSCOPIC DILATATION, PERSISTENT LARYNGOPHARYNGEAL SYMPTOMS (N-1), AND ACUTE CHEST PAIN (N-1). IN THE LNF GROUP, REPORTED COMPLICATIONS INCLUDED ANY DYSPHAGIA (58%) AND OTHER GI SYMPTOMS (SYMPTOMS OF BLOATING, FLATULENCE, DIARRHEA; 33%). THIS STUDY IS THE FIRST, TO THE AUTHOR¿S KNOWLEDGE, TO DIRECTLY COMPARE MSA WITH LNF. THE AUTHORS FIND THAT BOTH OPERATIONS HAVE SIMILAR SHORT-TERM EFFECTIVENESS FOR THE TREATMENT OF REFLUX DISEASE. IN CONCLUSION, THE AUTHORS FIND THAT THE MSA AND LNF ARE BOTH EFFECTIVE TREATMENTS FOR GERD. SEVERE DYSPHAGIA REQUIRING INTERVENTION OCCURS MORE FREQUENTLY FOLLOWING MSA THAN LNF. THE HIGHER RATE OF SIGNIFICANT DYSPHAGIA MUST BE WEIGHED AGAINST THE POSSIBILITY OF FEWER ¿WINDY¿ GI SIDE EFFECTS WHEN THE PATIENT AND SURGEON CHOOSE AN ANTI-REFLUX THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937805 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1