BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL ATTACHMENT

    MDR report key: 19606373 · Received June 25, 2024

    Report

    Report Number
    9614641-2024-01322
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    March 18, 2024
    Report Date
    July 2, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170047879
    PMA / PMN Number
    K984358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENTS CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). THE DEVICE WAS NOT RETURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000312.

    Description of Event or Problem · 0

    OBJECTIVE: ALTERATIONS TO INTERSTITIAL CELLS OF CAJAL (ICC) AND COLLAGEN FIBROSIS HAVE BEEN IMPLICATED IN THE PATHOGENESIS OF GASTROPARESIS. WE AIMED TO EVALUATE THE FEASIBILITY AND SAFETY OF PYLORIC MUSCLE SAMPLING DURING GASTRIC PERORAL ENDOSCOPIC MYOTOMY (G-POEM) AND THE ASSOCIATION BETWEEN PYLORIC ICC DENSITY AND DEGREE OF FIBROSIS WITH CLINICAL OUTCOMES. PATIENTS AND METHODS: THIS WAS A SINGLE-CENTER PROSPECTIVE STUDY. ICC COUNT WAS ESTIMATED USING CD117 STAIN AND TRICHOME FOR COLLAGEN FIBROSIS. CLINICAL RESPONSE TO G-POEM WAS DEFINED AS AN IMPROVEMENT OF = 1 POINT ON THE GASTROPARESIS CARDINAL SYMPTOM INDEX. RESULTS: FIFTY-SIX PATIENTS (MEDIAN AGE 60 YEARS, 71.4% WOMEN) UNDERWENT G-POEM (100% TECHNICAL SUCCESS; 71.4% CLINICAL RESPONSE). ICC DEPLETION (< 10/HIGH-POWER FIELD) AND FIBROSIS WERE ENCOUNTERED IN 70.4% AND 75% OF THE CASES, RESPECTIVELY. THERE WAS NO DIFFERENCE IN MEAN ICC COUNT BETWEEN G-POEM RESPONDERS VS. NON-RESPONDERS (7±3.6 VS. 7.7±3.3; P = 0.9). THERE WAS NO ASSOCIATION BETWEEN ICC DENSITY OR DEGREE OF FIBROSIS WITH THE ETIOLOGY OF GASTROPARESIS, DURATION OF SYMPTOMS, GASTRIC EMPTYING RATE, OR PYLORIC IMPEDANCE PLANIMETRY. PATIENTS WHO DID NOT RESPOND TO G-POEM HAD A SIGNIFICANTLY HIGHER DEGREE OF MODERATE/SEVERE FIBROSIS WHEN COMPARED WITH THOSE WHO RESPONDED (81.3% VS. 25%; P = 0.0002). CONCLUSIONS: PYLORIC MUSCLE BIOPSIES DURING G-POEM WAS FEASIBLE AND SAFE. ICC DEPLETION AND PYLORIC MUSCLE FIBROSIS ARE COMMON IN GASTROPARETIC PATIENTS. THE DEGREE OF FIBROSIS MAY BE RELATED TO PYLORIC DYSFUNCTION AND CLINICAL RESPONSE TO G-POEM. ADDITIONAL STUDIES ARE NEEDED TO CONFIRM THESE RESULTS. REPORTED ADVERSE EVENT: THERE WAS ONE AE (1.8%). IN THAT PATIENT, A MUCOSOTOMY WAS IDENTIFIED AFTER COMPLETION OF THE PYLOROMYOTOMY. THIS WAS ADEQUATELY CLOSED ON THE MUCOSAL SIDE WITH PLACEMENT OF TWO HEMOSTATIC CLIPS.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE ARTICLE "QUANTIFICATION OF INTERSTITIAL CELLS OF CAJAL AND FIBROSIS DURING GASTRIC PER-ORAL ENDOSCOPIC MYOTOMY AND ITS ASSOCIATION WITH CLINICAL OUTCOMES." THIS WAS A PROSPECTIVE STUDY OF GASTROPARETIC PATIENTS WHO UNDERWENT G-POEM AND INTRAPROCEDURAL PYLORIC MUSCLE BIOPSIES BETWEEN (B)(6) 2022 AND (B)(6) 2023. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. MUCOSOTOMY: 1 PATIENT. THIS WAS ADEQUATELY CLOSED ON THE MUCOSAL SIDE WITH PLACEMENT OF TWO HEMOSTATIC CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711582 DISTAL ATTACHMENT DISTAL ATTACHMENT FDS AOMORI OLYMPUS CO., LTD. MH-588 04953170047879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention EVIS EXERA GASTROINTESTINAL VIDEOSCOPE, GIF-H190.| SINGLE USE ELECTROSURGICAL KNIFE, KD-611L.