GEENEN PANCREATIC STENT
Report
- Report Number
- 3001845648-2020-00719
- Event Type
- Injury
- Date Received
- October 1, 2020
- Report Date
- December 14, 2021
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K900923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DEVICE EVALUATION: THE GEENEN PANCREATIC STENT , 5FR-3CM, 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, ¿UTILITY OF PLACEMENT OF PANCREATIC DUCT SPONTANEOUS DISLODGEMENT STENT FOR PREVENTION OF POST-ERCP PANCREATITIS IN PATIENTS WITH DIFFICULTY IN SELECTIVE BILIARY CANNULATION.¿ COMPLAINT FILES: (B)(4) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE (B)(4) (REPORT REFERENCE NUMBER - (B)(4)) WAS OPENED FOR PAIN AND HYPERAMYLASEMIA DUE TO THE OFF-LABEL PROPHYLACTIC USE OF THE GEENEN PANCREATIC STENT, 5FR-3CM.(RPN: UNKNOWN). (B)(4) (REPORT REFERENCE NUMBER - (B)(4)) WAS OPENED FOR STENT DISLODGMENT DUE TO THE OFF-LABEL PROPHYLACTIC USE OF THE ZIMMON PANCREATIC STENT, 5FR-4CM.(RPN: UNKNOWN). (B)(4) (REPORT REFERENCE NUMBER - (B)(4)) WAS OPENED FOR STENT DISLODGMENT DUE TO THE OFF-LABEL PROPHYLACTIC USE OF THE GEENEN PANCREATIC STENT, 5FR-3CM.(RPN: UNKNOWN). (B)(4) (REPORT REFERENCE NUMBER - (B)(4)) WAS OPENED FOR PAIN AND HYPERAMYLASEMIA DUE TO THE OFF-LABEL PROPHYLACTIC USE OF THE ZIMMON PANCREATIC STENT, 5FR-4CM.(RPN: UNKNOWN). (B)(4) (REPORT REFERENCE NUMBER - (B)(4)) WAS OPENED FOR STENT PLACEMENT FAILURE DUE TO THE OFF-LABEL PROPHYLACTIC USE OF THE GEENEN PANCREATIC STENT, 5FR-4CM.(RPN: UNKNOWN). (B)(4) (REPORT REFERENCE NUMBER - (B)(4)) WAS OPENED FOR STENT PLACEMENT FAILURE DUE TO THE OFF-LABEL PROPHYLACTIC USE OF THE ZIMMON PANCREATIC STENT, 5FR-4CM.(RPN: UNKNOWN). 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 (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 BEEN TESTED IN A CLINICAL SETTING. THE JAPANESE PACKAGING INSERT ((B)(4)) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. 198 PATIENTS WITH DIFFICULT BILIARY CANNULATION WERE SELECTED FOR THIS STUDY WITH 124 MALE PATIENTS AND 74 FEMALE PATIENTS, MEAN AGE WAS 68.2 YEARS OLD. IF IT WAS DIFFICULT TO CONDUCT SELECTIVE BILIARY CANNULATION BY A USUAL CANNULATION METHOD, 62 PATIENTS UNDERWENT PLACEMENT OF PANCREATIC DUCT GUIDEWIRE, 133 UNDERWENT PRECUT PAPILLOTOMY, AND 36 PATIENTS UNDERWENT BOTH PLACEMENT OF PANCREATIC DUCT GUIDEWIRE AND PRECUT PAPILLOTOMY. A 5FR 3CM STRAIGHT UNILATERAL-FLAPPED STENT (GEENEN PANCREATIC STENT: COOK MEDICAL) OR A 5FR 4CM STENT WITH A SINGLE DUODENAL PIGTAIL (ZIMMON PANCREATIC STENT: COOK MEDICAL) WERE USED AS PANCREATIC STENTS. THE SUCCESS RATE IN 99 PATIENTS WHO ATTEMPTED PLACEMENT OF A PANCREATIC DUCT STENT WAS 99.0% (98/99). ONE PATIENT, IN WHOM THE PLACEMENT FAILED HAD SUCCEEDED IN PLACEMENT ONCE BEFORE, BUT SUBSEQUENTLY, THE STENT DROPPED OUT DURING THE PROCEDURE CONDUCTED CONTINUOUSLY, AND THEREAFTER THE PLACEMENT COULD NOT BE PERFORMED. THE PANCREATIC DUCT STENT WAS SPONTANEOUSLY DISLODGED IN 2.06 DAYS (1 TO 13 DAYS) ON THE AVERAGE IN 94.9% (93/98) OF PATIENTS. IN 5 PATIENTS SHOWING NO SPONTANEOUS DISLODGEMENT, THE STENT WAS REMOVED ENDOSCOPICALLY AFTER 3 DAYS IN 3 PATIENTS, 4 DAYS IN 1 PATIENT AND 5 DAYS IN 1 PATIENT. CLINICAL INPUT RECEIVED CONFIRMED THAT THE PANCREATITIS WAS DUE TO ¿DIFFICULTY IN SELECTIVE BILIARY CANNULATION¿, THE PROPHYLACTIC USE OF PANCREATITIS STENT COULD PREVENT THE POST-ERCP PANCREATITIS. 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 198 PATIENTS WITH DIFFICULTY IN SELECTIVE BILIARY CANNULATION WERE INCLUDED TO EXAMINE WHETHER OR NOT PLACEMENT OF PANCREATIC DUCT STENT CAN PREVENT THE ONSET OF POST-ERCP PANCREATITIS. THERE WERE 99 PATIENTS WHO ATTEMPTED PLACEMENT OF A PANCREATIC DUCT STENT AND 99 WHO DID NOT ATTEMPT IT. AS THE STENTS WERE PLACED TO PREVENT POST-ERCP PANCREATITIS OCCURRING, THIS IS REGARDED AS OFF LABEL USE AS THE DEVICE WAS USED PROPHYLACTICALLY. ACCORDING TO THE INFORMATION REPORTED A 0.025-INCH OR 0.035-INCH GUIDE WIRE WAS USED (JAGWIRE: MICROVASIVE, BOSTON SCIENTIFIC CORP., NATICK, MA, REVO WAVE, OR VISIGLIDE: OLYMPUS CORP). HOWEVER, EVEN THOUGH THE USE OF 0.025 INCH WIRE GUIDE WOULD BE CONSIDERED USER ERROR WE HAVE NO DEFINITIVE CONFIRMATION OF WHICH OF THE TWO WAS INSERTED INTO THE PANCREATIC DUCT. SUMMARY: COMPLAINT IS BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED THE PANCREATITIS CAUSED BY STENT PLACEMENT FAILURE WAS RELIEVED WITH CONSERVATIVE TREATMENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SAKAI ET AL 2011 ¿UTILITY OF PLACEMENT OF PANCREATIC DUCT SPONTANEOUS DISLODGEMENT STENT FOR PREVENTION OF POST-ERCP PANCREATITIS IN PATIENTS WITH DIFFICULTY IN SELECTIVE BILIARY CANNULATION¿ WE EXAMINED WHETHER OR NOT PLACEMENT OF PANCREATIC DUCT STENT CAN PREVENT THE ONSET OF POST-ERCP PANCREATITIS BY COMPARING THE GROUP P(+) WITH PANCREATIC DUCT SPONTANEOUS DISLODGEMENT STENT PLACED AND THE GROUP P(-) WITH NO PANCREATIC DUCT STENT PLACED IN PATIENTS WITH DIFFICULTY IN SELECTIVE BILIARY CANNULATION, A RISK FACTOR OF POST-ERCP PANCREATITIS. FROM APRIL 2005 TO JULY 2010 198 PATIENTS WITH DIFFICULTY IN SELECTIVE BILIARY CANNULATION WERE INCLUDED. THERE WERE 124 MALE PATIENTS AND 74 FEMALE PATIENTS, THE MEAN AGE WAS 68.2 YEARS OLD (24 TO 93 YEARS OLD), AND THE PATIENTS INCLUDED 86 WITH BILE DUCT STONE, 43 WITH CHOLANGIOCARCINOMA, 38 WITH PANCREATIC CANCER, 6 WITH GALLBLADDER CANCER, 5 WITH CHRONIC PANCREATITIS, 4 WITH PSC, 4 WITH BENIGN BILIARY STRICTURE, 3 WITH PAPILLARY CARCINOMA, 2 WITH POSTOPERATIVE BILIARY FISTULA, 2 WITH AUTOIMMUNE PANCREATITIS, 2 WITH HCC, 1 WITH OVARIAN CANCER, 1 WITH GALLBLADDER POLYP, AND 1 WITH PANCREATICOBILIARY MALJUNCTION. 0.025-INCH OR 0.035-INCH GUIDEWIRE (JAGWIRE: MICROVASIVE, BOSTON SCIENTIFIC CORP., NATICK, MA, REVO WAVE, OR VISIGLIDE: OLYMPUS CORP.) WAS USED. A 5FR 3CM STRAIGHT UNILATERAL-FLAPPED STENT (GEENEN PANCREATIC STENT: COOK MEDICAL CORP. NORTH CAROLINA USA), OR A 5FR 4CM STENT WITH A SINGLE DUODENAL PIGTAIL (ZIMMON PANCREATIC STENT: COOK MEDICAL CORP. NORTH CAROLINA, USA) WERE USED AS PANCREATIC STENTS. THERE WERE 99 PATIENTS WHO ATTEMPTED PLACEMENT OF A PANCREATIC DUCT STENT AND 99 WHO DID NOT ATTEMPT IT. THE SUCCESS RATE IN 99 PATIENTS WHO ATTEMPTED PLACEMENT OF A PANCREATIC DUCT STENT WAS 99.0% (98/99). ONE (1) PATIENT IN WHOM THE PLACEMENT FAILED HAD SUCCEEDED IN PLACEMENT ONCE BEFORE, BUT SUBSEQUENTLY, THE STENT DROPPED OUT DURING THE PROCEDURE CONDUCTED CONTINUOUSLY, AND THEREAFTER THE PLACEMENT COULD NOT BE PERFORMED. POST-ERCP PANCREATITIS WAS OBSERVED IN 7.07% OF PATIENTS (14/198). IN THE P(+) GROUP, THE INCIDENCE OF PANCREATITIS WAS 3.0% (3/99 PATIENTS), THAT OF ABDOMINAL PAIN WAS 3.0% (3/99), THAT OF HYPERAMYLASEMIA WAS 16.2% (16/99). THE PANCREATIC DUCT STENT WAS SPONTANEOUSLY DISLODGED IN 2.06 DAYS (1 TO 13 DAYS) ON THE AVERAGE IN 94.9% (93/98) OF PATIENTS. ON 5 PATIENTS SHOWING NO SPONTANEOUS DISLODGEMENT, THE STENT WAS REMOVED ENDOSCOPICALLY AFTER 3 DAYS IN 3 PATIENTS, 4 DAYS IN 1 PATIENT AND 5 DAYS IN 1 PATIENT. THE STENT PLACEMENT FAILED CAUSING PANCREATITIS IN 1 PATIENT. THIS CASE WAS RELIEVED BY CONSERVATIVE TREATMENT. THIS FILE WAS CREATED TO CAPTURE THE STENT PLACEMENT FAILURE WHICH CAUSED PANCREATITIS AND HAD TO BE TREATED CONSERVATIVELY IN GEENEN (5FR, 3CM) DEVICE. THIS FILE IS ALSO RELATED TO OFF LABEL USE AS IT WAS PLACED PROPHYLACTICALLY. A SEPARATE FILE HAS BEEN CREATED TO CAPTURE THE ZIMMON DEVICE. ADDITIONAL FILES HAVE ALSO BEEN CREATED TO CAPTURE GENERAL OFF LABEL, ABDOMINAL PAIN AND HYPERAMYLASEMIA WHICH IS ASSOCIATED WITH OFF LABEL ALSO. EXACT RPN CANNOT BE CONFIRMED, POTENTIAL RPN¿S ARE GEPD-5-3, GPDS-5-3, GPSO-5-3 OR GPSOS-5-3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1081568 | GEENEN PANCREATIC STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Required Intervention |