BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEENEN PANCREATIC STENT SET

    MDR report key: 10604865 · Received September 30, 2020

    Report

    Report Number
    3001845648-2020-00684
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE GEENEN PANCREATIC STENT 5FR, 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. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE, "STENT PLACEMENT IN THE PANCREATIC DUCT PREVENTS PANCREATITIS AFTER ENDOSCOPIC SPHINCTER DILATION FOR REMOVAL OF BILE DUCT STONES". COMPLAINT FILES (B)(4) (MDR REF #3001845648-2020-00684), (B)(4) (MDR REF # 3001845648-2020-00686) AND (B)(4) (MDR REF #3001845648-2020-00685) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE WAS OPENED FOR 30 CASES OF OFF-LABEL PROPHYLACTIC USE OF THE GEENEN PANCREATIC STENT AND USER ERROR OF AN INCORRECT SIZE WIREGUIDE 0.018IN THAT WAS USED. (RPN: UNKNOWN) (B)(4) (MDR REF # 3001845648-2020-00686) WAS OPENED FOR 3 CASES OF STENT OCCLUSION DUE TO OFF-LABEL PROPHYLACTIC USE OF THE GEENEN PANCREATIC STENT. (RPN: UNKNOWN) (B)(4) (MDR REF #3001845648-2020-00685) WAS OPENED FOR 5 CASES OF STENT DISLODGEMENT DUE TO OFF-LABEL PROPHYLACTIC USE OF THE ZIMMON PANCREATIC STENT AND USER ERROR OF AN INCORRECT SIZE WIREGUIDE 0.018IN THAT WAS USED. (RPN: SPSOF-5-2.5) DOCUMENT REVIEW: 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 ZIMMON 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 (IFU0055-4) "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.¿ 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. A GEENEN STRAIGHT 30-MM STENT WAS PLACED IN 17 PATIENTS, A GEENEN 50-MM STRAIGHT STENT IN 16 PATIENTS. THIS FILE IS CAPTURING THE 30MM STENT PLACED IN 17 PATIENTS AND A 50MM STENT PLACED IN 13 PATIENTS (13 HAD NO ADVERSE EFFECTS AND ARE CAPTURING THE OFF-LABEL USE WITHIN THIS FILE) WHILE (B)(4) (MDR REF # 3001845648-2020-00686) CAPTURES THE STENT OCCLUSION IN 3 PATIENTS WITH THE 5FR-50MM STENT. ROOT CAUSE: 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. IN THIS STUDY, 38 PATIENTS HAD STENTS PLACED IN THE PANCREATIC DUCT IN THE PANCREATIC DUCT AFTER ENDOSCOPIC SPHINCTER DILATION. STENTS INSERTED INCLUDED A 5FR-30MM AND 5FR-50MM GEENEN PANCREATIC STENT (COOK MEDICAL) AND 5FR-2.5MM ZIMMON PANCREATIC STENT WITH A CURLED TAIL (COOK MEDICAL). THE AIM OF PLACING THE STENTS WAS TO TRY AND REDUCE THE FREQUENCY OF PANCREATITIS AND HYPERAMYLASEMIA, THIS IS REGARDED AS OFF LABEL USE AS THE DEVICE WAS USED PROPHYLACTICALLY. 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. SUMMARY: COMPLAINT IS BASED ON CUSTOMER TESTIMONY. ACCORDING 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

    THE INVESTIGATION WAS CONCLUDED ON THE 26-AR-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

    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 THIS FILE WAS CREATED TO CAPTURE THE 17 GEENEN 5FR 30MM AND 13 GEENEN 50-MM STRAIGHT STENT, OFF LABEL PROPHYLACTIC USE. USER ERROR IS ALSO CAPTURED UNDER THIS FILE AS AN INCORRECT SIZE WIRE GUIDE WAS USED (0.018 INCH). AN ADDITIONAL FILE WAS CREATED TO CAPTURE THE 3 OCCLUSION DEVICES UNDER GEENEN 5FR 50MM, THIS FILE IS ALSO RELATED TO OFF LABEL USE. THE EXACT RPN CANNOT BE CONFIRMED, POSSIBLE RPNS ARE GEPD-5-3, GPDS-5-3, GEPD-5-5 OR GPDS-5-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069534 GEENEN PANCREATIC STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR