BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANCREATIC STENT

    MDR report key: 13505472 · Received February 10, 2022

    Report

    Report Number
    8010047-2022-02728
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    January 9, 2022
    Report Date
    July 6, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGE
    UDI-DI
    04953170152160
    PMA / PMN Number
    K021672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. NEW INFORMATION WAS ADDED TO THE FOLLOWING FIELDS: D4, H6, H10. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE 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 EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: EARLY ENDOSCOPIC TREATMENT OF SYMPTOMATIC PANCREATIC NECROTIC COLLECTIONS BY BY M.JAGIELSKI, J. PIATKOWSKI AND M. JACKOWSKI. ABSTRACT: ENDOSCOPIC ULTRA-SOUND (EUS)-GUIDED TRANSMURAL ENDOSCOPIC DRAINAGE IS COMMONLY USED IN THE TREATMENT OF WALLED OFF PANCREATIC NECROSIS (WOPN) IN THE LATE PHASE OF ACUTE NECROTIC PANCREATITIS (ANP). THE ROLE OF ENDOSCOPIC INTERVENTION REMAINS UNCLEAR IN THE EARLY PHASE OF ANP. THIS STUDY AIMED TO PROSPECTIVELY EVALUATE EARLY ENDOSCOPIC TREATMENT OF ANCS COMPARED WITH ENDOSCOPIC DRAINAGE OF WOPN. OVERALL, 71 PATIENTS WITH ANP WHO UNDERWENT TRANSMURAL ENDOSCOPIC DRAINAGE FOR NECROTIC COLLECTIONS WERE INCLUDED. ENDOSCOPIC INTERVENTION WAS PERFORMED WITHIN THE FIRST FOUR WEEKS OF ANP IN 25 (35.21%) PATIENTS WITH ANC (GROUP 1) AND IN 46 (64.79%) PATIENTS AFTER FOUR WEEKS SINCE THE ONSET OF ANP WITH WOPN (GROUP 2). THE OVERALL MEAN AGE OF PATIENTS WAS 49.9 (22¿79) YEARS AND 59 OF THEM WERE MALES. THE MEAN TIME OF ACTIVE DRAINAGE AND DURATION OF TOTAL ENDOSCOPIC TREATMENT WAS 26.8 AND 16.9 DAYS (P= 0.0001) AND 270.8 AND 164.2 DAYS (P= 0.0001) IN GROUPS 1 AND 2, RESPECTIVELY. THE AVERAGE TOTAL NUMBER OF ENDOSCOPIC INTERVENTIONS WAS 9.5 AND 4.5 IN GROUPS 1 AND 2, RESPECTIVELY (P= 0.0001). THE CLINICAL SUCCESS RATE, FREQUENCY OF COMPLICATIONS OF ENDOSCOPIC INTERVENTIONS, LONG-TERM SUCCESS RATE, AND RECURRENCE RATE WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE GROUPS (P> 0.05 FOR EACH). TRANSMURAL ENDOSCOPIC DRAINAGE IS EFFECTIVE METHOD OF TREATMENT OF EARLY ANCS WITHIN THE FIRST FOUR WEEKS OF ANP. HOWEVER, COMPARED WITH ENDOSCOPIC INTERVENTION IN WOPN, MORE INTERVENTIONS AND LONGER DURATION OF DRAINAGE ARE REQUIRED. THE FOLLOWING ADVERSE EVENTS AND MALFUNCTION WAS REPORTED: 10 PATIENTS WITH GASTROINTESTINAL BLEEDING (REQUIRED TRANSFUSIONS) 1 PATIENT WITH GASTROINTESTINAL PERFORATION (TREATED CONSERVATIVELY) LATE COMPLICATIONS OCCURRING MORE THAN 30 DAYS AFTER TREATMENT: 21 NEWLY DIAGNOSED INSULIN-DEPENDENT DIABETES 25 VENOUS THROMBOSIS (INVOLVING SPLENIC OR PORTAL VEIN) THE AUTHORS REPORTED USE OF 3 OLYMPUS DEVICES. THIS EVENT INCLUDES 3 REPORTS: (B)(6) - OLYMPUS TJF-Q180V. (B)(6) - OLYMPUS GIF-H185 WITH INSUFFLATION OF CO2. (B)(6) - OLYMPUS PBD-234-0806. THIS IS REPORT 3 OF 3 FOR (B)(6) - OLYMPUS PBD-234-0806.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257905 PANCREATIC STENT PANCREATIC DRAINAGE TUBE FGE OLYMPUS MEDICAL SYSTEMS CORP. PBD-234-0806 UNKNOWN (LITERATURE) 04953170152160

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L| O