BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEENEN PANCREATIC STENT SET

    MDR report key: 10633751 · Received October 6, 2020

    Report

    Report Number
    3001845648-2020-00750
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Report Date
    March 26, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IMDRF ANNEX G CODE: G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. DEVICE EVALUATION: THE GEENEN PANCREATIC STENT OF UNKNOWN LOT NUMBER AND RPN INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE. ¿CONTEMPORARY MANAGEMENT OF PANCREATICOPLEURAL FISTULAS COMPLICATING ACUTE PANCREATITIS " AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL GEENEN PANCREATIC STENT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE (IFU (B)(4) AND IFU (B)(4)) "THIS DEVICE IS USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ AS PER THE INFORMATION REPORTED IN THE PAPER A GEENEN PANCREATIC STENT WAS USED TO TREAT A PATIENT WITH A PANCREATICOPLEURAL FISTULA WHEN IT ¿WAS INSERTED INTO THE PANCREATIC DUCT AND POSITIONED ACROSS THE SITE OF LEAKAGE, WITHOUT PANCREATIC DUCT SPHINCTEROTOMY.¿ THE USE OF THE DEVICE IN THIS FASHION IS REGARDED AS OFF LABEL USE A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE ITS STATED INTENDED USE IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. WHERE THE USE OF THE DEVICE TO THREAT A FISTULA IS NOT A STATED USE AS PER THE IFU AND THEREFORE HAS NOT BEING TESTED IN A CLINICAL SETTING. COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, A RAPID DECREASE IN PLEURAL FISTULA OUTPUT, WITH COMPLETE CESSATION OF DRAINAGE WITHIN 72 HOURS WAS OBSERVED. THE PATIENT WAS DISCHARGED 18 DAYS LATER AND THE STENT WAS REMOVED 2 MONTHS AFTER INSERTION, THE PATIENT WAS ASYMPTOMATIC 12 MONTHS AFTER DISCHARGE FROM HOSPITAL. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE INVESTIGATION WAS CONCLUDED ON THE (B)(6) 2021, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS WITHIN SECTION H.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    MACDUFF ET AL 2000 ¿CONTEMPORARY MANAGEMENT OF PANCREATICOPLEURAL FISTULAS COMPLICATING ACUTE PANCREATITIS¿ A 45-YEAR-OLD WOMAN PRESENTED TO THE RESPIRATORY MEDICINE UNIT WITH A 10-DAY HISTORY OF RAPIDLY PROGRESSIVE DYSPNOEA. A DIAGNOSIS OF PANCREATICOPLEURAL FISTULA WAS MADE AND THE PATIENT WAS REFERRED TO OUR UNIT. ERCP SHOWED A NON-DILATED PANCREATIC DUCT, WITH EVIDENCE OF A RETROPERITONEAL TRACT COMMUNICATING WITH THE RIGHT PLEURAL CAVITY AN ENDOSCOPIC STENT (GEENEN PANCREATIC STENT, 5 F, WILSON-COOK MEDICAL INC., WINSTON , SALEM, NC, USA) WAS INSERTED INTO THE PANCREATIC DUCT AND POSITIONED ACROSS THE SITE OF LEAKAGE, WITHOUT PANCREATIC DUCT SPHINCTEROTOMY. THERE WAS A RAPID DECREASE IN PLEURAL FISTULA OUTPUT, WITH COMPLETE CESSATION OF DRAINAGE WITHIN 72 H. THIS REDUCTION WAS ASSOCIATED WITH A MARKED CLINICAL IMPROVEMENT. THE ENDOSCOPIC STENT WAS REMOVED 2 MONTHS AFTER INSERTION. ENDOSCOPIC PANCREATOGRAM AT THE T IME OF STENT REMOVAL SHOWED NO ONGOING EXTRAVASATION, BUT INDICATED THE PRESENCE OF A FOCAL STRICTURE AT THE SITE OF THE ORIGINAL LEAK. THE PATIENT WAS ASYMPTOMATIC 12 MONTHS AFTER DISCHARGE FROM HOSPITAL. THIS FILE IS BEING CREATED TO CAPTURE THE OFF LABEL USE OF THE GEENEN PANCREATIC STENT AS IT WAS USED TO TREAT A FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102331 GEENEN PANCREATIC STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR