BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEENEN PANCREATIC STENT SET

    MDR report key: 10605329 · Received September 30, 2020

    Report

    Report Number
    3001845648-2020-00686
    Event Type
    Injury
    Date Received
    September 30, 2020
    Date of Event
    March 9, 2001
    Report Date
    April 26, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE GEENEN PANCREATIC STENT, 5FR-50MM 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 OPENED FOR 3 CASES OF STENT OCCLUSION DUE TO OFF-LABEL PROPHYLACTIC USE OF THE GEENEN PANCREATIC STENT AND USER ERROR OF AN INCORRECT SIZE WIREGUIDE 0.018IN THAT WAS USED. 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 "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.¿ WHERE THE PROPHYLACTIC USE OF THE DEVICE IN THIS PROCEDURE IS NOT A STATED USE AS PER THE IFU AND THEREFORE HAS NOT BEING TESTED IN A CLINICAL SETTING. IN THIS STUDY STENT PLACEMENT TOOK PLACE IN 38 PATIENTS IN THE PANCREATIC DUCT TO DETERMINE IF IT DECREASED THE FREQUENCY OF PANCREATITIS AND HYPERAMYLASAEMIA. THREE TYPES OF STENTS WERE USED; 5FR, 30 AND 50MMIN LENGTH(COOK MEDICAL) AND A 5FR, 2.5CM ZIMMON STENT WITH CURLED-TAIL. FOLLOWING ESD (ENDOSCOPIC SPHINCTER DILATION) AND STONE EXTRACTION, A 0.018INCH WIREGUIDE WAS (PATHFINDER, BOSTON SCIENTIFIC CORP.) WAS PASSED THROUGH THE DIAGNOSTIC CATHETER AND INTO THE MAIN PANCREATIC DUCT. A 5FR STENT WITH SIDE-HOLES, EITHER 30 OR 50MM IN LENGTH (GEENEN, WILSON-COOK) WAS THEN PASSED OVER THE GUIDEWIRE AND POSITIONED ACROSS THE PAPILLA WITH A SPECIAL PUSHING TUBE. THE OVERALL SUCCESS RATE FOR PANCREATIC DUCT STENT PLACEMENT WAS 95% (38 OF 40 PATIENTS), STENT PLACEMENT WAS UNSUCCESSFUL IN 1 PATIENT BECAUSE THE GUIDEWIRE CAME OUT OF THE PAPILLA DURING STENT PLACEMENT WHILE CANNULATION OF THE PANCREATIC DUCT WAS NOT ACHIEVED IN THE OTHER PATIENT IN WHOM A PANCREATIC STENT COULD NOT BE PLACED. STENT OCCLUSION WAS FOUND IN 3 PATIENTS IN WHOM A 50MM STRAIGHT STENT HAD BEEN PLACED. A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE IT STATED INTENDED USE IN THIS CASE PROPHYLACTIC USE OF THE DEVICE. IT CAN RESULT IN OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. 38 PATIENTS IN TOTAL HAD SUCCESSFUL PANCREATIC DUCT STENT PLACEMENT ACROSS THE MAJOR DUODENAL PAPILLA INVOLVING ZIIMMON PANCREATIC STENTS AND GEENEN PANCREATIC STENTS (COOK MEDICAL) IN ORDER TO PREVENT ESD-RELATED PANCREATITIS. THIS IS REGARDED AS OFF LABEL USE AS THE DEVICE WAS USED PROPHYLACTICALLY. IN THIS STUDY, STENT OCCLUSION OCCURRED IN 3 PATIENTS WHO HAD THE GEENEN PANCREATIC STENT, 5FR, 50MM (RPN: UNKNOWN) PLACED AFTER STONE EXTRACTION IN ORDER TO AVOID FURTHER ENDOSCOPIC PROCEDURES. IT MAY BE NOTED THAT STENT OCCLUSION IS LISTED AS A POTENTIAL COMPLICATION IN THE INSTRUCTIONS FOR USE UNDER "OBSTRUCTION OF THE COMMON BILE DUCT". HOWEVER, IT MUST BE TAKEN INTO ACCOUNT THAT THESE STENTS WERE USED OFF-LABEL WHICH MAY HAVE BEEN AN INFLUENTIAL FACTOR ON THIS OCCLUSION. USER ERROR OF AN INCORRECT SIZED WIREGUIDE ALSO OCCURRED. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. AS PER INFORMATION REPORTED A 0.018" WIRE GUIDE (PATHFINDER, BOSTON SCIENTIFIC CORP) WAS USED. COMPLAINT IS BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED STENT OCCLUSION OCCURRED IN 3 PATIENTS. CCORDING TO THE INFORMATION REPORTED THERE WAS NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE OFF-LABEL USE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    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

    AIZAWA ET AL. 2001 STENT PLACEMENT IN THE PANCREATIC DUCT PREVENTS PANCREATITIS AFTER ENDOSCOPIC SPHINCTER DILATION FOR REMOVAL OF BILE DUCT STONES. THIS IS A PROSPECTIVE STUDY TO DETERMINE WHETHER TEMPORARY PLACEMENT OF A STENT IN THE PANCREATIC DUCT PROTECTS AGAINST ESD-RELATED PANCREATITIS. PANCREATIC DUCT STENT PLACEMENT ACROSS THE MAJOR DUODENAL PAPILLA WAS ATTEMPTED BETWEEN DECEMBER 1997 AND AUGUST 1999 IN 40 CONSECUTIVE PATIENTS UNDERGOING ESD FOR REMOVAL OF BILE DUCT STONES. STENT INSERTION WAS SUCCESSFUL IN 38 PATIENTS. THREE TYPES OF PANCREATIC STENTS WERE USED: 5F GEENEN (NOT AMSTERDAM) 30 AND 50 MM IN LENGTH (WILSON-COOK MEDICAL, INC., WINSTON-SALEM, N.C.), AND A 5F, 2.5-CM ZIMMON STENT WITH CURLED-TAIL (WILSON-COOK). SUBSEQUENT TO ESD AND STONE EXTRACTION A PANCREATOGRAM WAS OBTAINED AND THEN A 0.018-INCH GUIDEWIRE (PATHFINDER, BOSTON SCIENTIFIC CORP.) WAS PASSED THROUGH THE DIAGNOSTIC CATHETER AND INTO THE MAIN PANCREATIC DUCT. A 5F STENT WITH SIDE-HOLES, EITHER 30 OR 50 MM IN LENGTH (GEENEN, WILSON-COOK) WAS THEN PASSED OVER THE GUIDEWIRE AND POSITIONED ACROSS THE PAPILLA WITH A SPECIAL PUSHING TUBE. THE PANCREATIC STENTS OR DRAINAGE CATHETERS WERE REMOVED 3 DAYS LATER AT A SUBSEQUENT ENDOSCOPIC PROCEDURE. WHEN STONE EXTRACTION WAS COMPLETE AT THE INITIAL PROCEDURE, AN ATTEMPT WAS MADE TO AVOID FURTHER ENDOSCOPIC PROCEDURES BY PLACING A 5F, 2.5-CM ZIMMON STENT (WILSON-COOK) THAT HAS A SINGLE SIDE FLAP AT THE TIP AND A CURLSHAPED TAIL WITH THE EXPECTATION THAT THIS STENT WOULD DISLODGE AND PASS SPONTANEOUSLY. AN ATTEMPT WAS MADE TO PLACE THIS TYPE OF STENT IN 5 PATIENTS AND WAS SUCCESSFUL IN ALL CASES BY USING THE SAME TECHNIQUE AS DESCRIBED ABOVE FOR PLACEMENT OF THE GEENEN STENT. A GEENEN STRAIGHT 30-MM STENT WAS PLACED IN 17 PATIENTS, A GEENEN 50-MM STRAIGHT STENT IN 16, AND A ZIMMON CURLED-TAIL STENT IN 5 PATIENTS STENT OCCLUSION WAS FOUND IN 3 PATIENTS IN WHOM A 50-MM STRAIGHT STENT HAD BEEN PLACED. THIS WAS THOUGHT TO BE CAUSED BY NECROTIC TISSUE OR A PROTEIN PLUG IN THE STENT. THIS FILE WAS CREATED TO CAPTURE STENT OCCLUSION OF THREE GEENAN 5FR, 50MM DEVICES, THIS FILE IS ALSO RELATED TO OFF LABEL USE AS THE DEVICE WAS PLACED FOR PROPHYLACTIC USE. AN ADDITIONAL FILE WAS CREATED TO CAPTURE THE OFF LABEL DEVICES THAT DID NOT RESULT IN AN ADVERSE EVENT ((B)(4)). THE EXACT RPN CANNOT BE CONFIRMED, POSSIBLE RPNS ARE GEPD-5-5 OR GPDS-5-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074962 GEENEN PANCREATIC STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention