BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T LINX, 15B

    MDR report key: 10194960 · Received June 25, 2020

    Report

    Report Number
    3008766073-2020-00091
    Event Type
    Injury
    Date Received
    June 25, 2020
    Report Date
    June 9, 2020
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005356
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: DEVELOPMENT OF PSEUDOACHALASIA FOLLOWING MAGNETIC SPHINCTER AUGMENTATION (MSA) WITH RESTORATION OF PERISTALSIS AFTER ENDOSCOPIC DILATION AUTHORS: KATRIN SCHWAMEIS, SHAHIN AYAZI, ALI H. ZAIDI, TOSHITAKA HOPPO, BLAIR A. JOBE CITATION: CLINICAL JOURNAL OF GASTROENTEROLOGY; HTTPS://DOI.ORG/10.1007/S12328-020-01140-5. THIS PRESENTED A CASE OF PSEUDOACHALASIA FOLLOWING MAGNETIC SPHINCTER AUGMENTATION (MSA) WITH SUCCESSFUL RESTORATION OF ESOPHAGEAL PERISTALSIS AFTER ENDOSCOPIC DILATION. A (B)(6) CAUCASIAN MALE WITH A LONG-STANDING HISTORY OF GASTROESOPHAGEAL REFLUX DISEASE (GERD) WAS INCLUDED IN THIS CASE REPORT. HIS PRIMARY SYMPTOM WAS HEARTBURN FOR WHICH HE WAS ON PROTON PUMP INHIBITOR (PPI) FOR 7 YEARS. HIS ESOPHAGRAM SHOWED A SMALL [1 CM] HIATAL HERNIA AND NO EVIDENCE OF ESOPHAGEAL DYSMOTILITY; ESOPHAGOGASTRODUODENOSCOPY (EGD) RECONFIRMED THE PRESENCE OF SMALL HIATAL HERNIA WITH NO EVIDENCE OF ESOPHAGITIS. SUBSEQUENTLY, HE UNDERWENT LAPAROSCOPIC HIATAL HERNIA REPAIR AND MAGNETIC SPHINCTER AUGMENTATION USING A SIZE 15 LINX REFLUX MANAGEMENT SYSTEM (ETHICON). A FEW DAYS AFTER SURGERY, HE PRESENTED WITH COMPLAINT OF CHEST PAIN AND DYSPHAGIA; HOWEVER, THESE SYMPTOMS WERE COMPLETELY RESOLVED WITH ADHERENCE TO THE POST-LINX DIET CONSISTED OF FREQUENT SMALL MEALS AND A SHORT COURSE OF ORAL STEROIDS. AT HIS 6-WEEK FOLLOW-UP VISIT, THE PATIENT REPORTED COMPLETE RESOLUTION OF HIS REFLUX SYMPTOMS AND HAD NO COMPLAINT OF CHEST PAIN OR DYSPHAGIA. FOURTEEN MONTHS AFTER SURGERY, HE PRESENTED WITH COMPLAINT OF PROGRESSIVE DYSPHAGIA WHICH PROMPTED AN OBJECTIVE FOREGUT EVALUATION. HOWEVER, HIS ESOPHAGRAM REVEALED POOR RELAXATION OF THE EGJ WITH HOLD-UP OF THE LIQUID BARIUM CONTRAST ABOVE THE ESOPHAGOGASTRIC JUNCTION (EGJ) AND HIGH-RESOLUTION IMPEDANCE MANOMETRY (HRIM) SHOWED COMPLETE APERISTALSIS OF THE ESOPHAGEAL BODY WITH 100% INCOMPLETE BOLUS CLEARANCE ON IMPEDANCE ANALYSIS OF HRIM AND A NON-RELAXING LES WITH ELEVATED INTEGRATED RELAXATION PRESSURE (IRP) OF 21.2 MMHG. THE PATIENT WAS SCHEDULED FOR AN EGD WHICH SHOWED APPROPRIATE POSITION OF THE LINX DEVICE WITH NO EVIDENCE OF HERNIATION OR EROSION, BUT MODERATE DEGREE OF RESISTANCE AT THE EGJ. ENDOSCOPIC DILATION WITH 57- AND 60-FRENCH SAVARY DILATORS WAS PERFORMED THAT LED TO PARTIAL RELIEF OF HIS DYSPHAGIA. EIGHT WEEKS LATER, HE UNDERWENT ANOTHER EGD WITH ENDOSCOPIC DILATION WITH 15¿18-MM DIAMETER THROUGH-THE-SCOPE (TTS) BALLOON THAT RESULTED IN COMPLETE RESOLUTION OF HIS DYSPHAGIA. A FOLLOW-UP HRIM 3 WEEKS LATER SHOWED RESTORATION OF PERISTALTIC ESOPHAGEAL CONTRACTIONS WITH NORMAL MEAN WAVE AMPLITUDE AND DCI AND A COMPLETELY RELAXING LES WITH NORMALIZATION OF INTEGRATED RELAXATION PRESSURE (IRP) AND A NORMAL INTRABOLUS PRESSURE (IBP). THE PATIENT HAS REMAINED FREE OF THE SYMPTOM OF DYSPHAGIA SINCE THEN. IN CONCLUSION, INCREASED ESOPHAGEAL OUTFLOW RESISTANCE FOLLOWING ANTI-REFLUX SURGERY CAN LEAD TO THE DEVELOPMENT OF EGJ OUTLET OBSTRUCTION (EGJOO). IN EXTREME CASES, THIS WILL LEAD TO IMPAIRMENT OF ESOPHAGEAL BODY CONTRACTION AND DEVELOPMENT OF PSEUDOACHALASIA. UNLIKE THE PSEUDOACHALASIA CASES DEVELOPED AFTER NISSEN FUNDOPLICATION, IN THIS MSA CASE, RESOLUTION OF DYSPHAGIA AND COMPLETE RESTORATION OF PERISTALTIC CONTRACTION WAS OBSERVED AFTER ENDOSCOPIC DILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661011 1.5T LINX, 15B ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC15 00855106005356

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention