GEENEN PANCREATIC STENT
Report
- Report Number
- 3001845648-2020-00693
- Event Type
- Malfunction
- Date Received
- September 30, 2020
- Date of Event
- August 23, 2009
- Report Date
- July 29, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K900923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 ATTACHED JOURNAL ARTICLE "DIFFICULT BILIARY CANNULATION: USE OF PHYSICIAN-CONTROLLED WIRE-GUIDED CANNULATION OVER A PANCREATIC DUCT STENT TO REDUCE THE RATE OF PRECUT" (COTE ET AL 2009). COMPLAINT FILES (B)(4). (REPORT REFERENCE NUMBER 3001845648-2020-00692) AND PR309265 (REPORT REFERENCE NUMBER 3001845648-2020-00693) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE COVERS THE CASES OF MILD POST - ERCP PANCREATITIS DUE TO OFF-LABEL USE. (RPN UNKNOWN) PR309254 COVERS THE OFF LABEL USE OF GEENEN PANCREATIC STENT TO FACILITY BILIARY CANNULATION. (RPN UNKNOWN) 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 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. THE INSTRUCTIONS OF USE (IFU0055-4) WHICH WOULD ACCOMPANY THIS DEVICE INSTRUCTS THE USER TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ 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.¿ THERE WERE 4 PATIENTS (5.3%) CASES OF MILD POST-ERCP PANCREATITIS, 2 OF WHICH OCCURRED IN PATIENTS WHO HAD THEIR PD STENT REMOVED AT THE COMPLETION OF THE PROCEDURE. ROOT CAUSE REVIEW 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. AS PER CLINICAL INPUT RECEIVED, THE PANCREATITIS THAT OCCURRED CAN BE ATTRIBUTED TO THE ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE THAT OCCURRED, THIS IS REGARDED AS OFF-LABEL USE. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION RECEIVED THERE WERE 4 (5.3%) CASES OF MILD POST-ERCP PANCREATITIS, 2 OF WHICH WERE COMPLICATED BY BLEEDING DURING THE PROCEDURE. BLEEDING WAS SUCCESSFULLY CONTROLLED WITH SUBMUCOSAL INJECTION OF EPINDEPHRINE, NO OTHER PROCEDURE-RELATED COMPLICATIONS WERE IDENTIFIED.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
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 ATTACHED JOURNAL ARTICLE "DIFFICULT BILIARY CANNULATION: USE OF PHYSICIAN-CONTROLLED WIRE-GUIDED CANNULATION OVER A PANCREATIC DUCT STENT TO REDUCE THE RATE OF PRECUT". COMPLAINT FILES (B)(4) (3001845648-2020-00692) AND (B)(4) (3001845648-2020-00693) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE COVERS THE CASES OF MILD POST - ERCP PANCREATITIS. (RPN UNKNOWN) (B)(4) COVERS THE OFF LABEL USE OF GEENEN PANCREATIC STENT TO FACILITY BILIARY CANNULATION. (RPN UNKNOWN) 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 GEENEN PANCREATIC STENT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THE INSTRUCTIONS OF USE (IFU0055-4) WHICH WOULD ACCOMPANY THIS DEVICE INSTRUCTS THE USER TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ 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.¿ THERE WERE 4 PATIENTS (5.3%) CASES OF MILD POST-ERCP PANCREATITIS, 2 OF WHICH OCCURRED IN PATIENTS WHO HAD THEIR PD STENT REMOVED AT THE COMPLETION OF THE PROCEDURE. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE ERCP PROCEDURE CAUSING ERCP- ASSOCIATED PANCREATITIS. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION RECEIVED THERE WERE 4 (5.3%) CASES OF MILD POST-ERCP PANCREATITIS, 2 OF WHICH OCCURRED IN PATIENTS WHO HAD THEIR PD STENT REMOVED AT THE COMPLETION OF THE PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
SUPPLEMENTAL REPORT BEING SUBMITTED TO REPORT UPDATES TO THE FILE ON (B)(6) 2022.
ADDITIONAL INFORMATION: CLINICAL INPUT CONFIRMS ON (B)(6) 2021 THAT PANCREATITIS WAS NOT CAUSED CONTRIBUTED BY STENT, THIS FILE NO LONGER MEETS THE REQUIREMENTS OF ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. THIS SUPPLEMENT REPORT IS BEING MADE TO AMEND THE PREVIOUS REPORT SUBMITTED TO A MALFUNCTION REPORT TO CAPTURE OFF LABEL USE OF THE DEVICE.
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.
COTE ET AL 2009 (GEENEN PS) ¿ ¿DIFFICULT BILIARY CANNULATION: USE OF PHYSICIAN-CONTROLLED WIRE-GUIDED CANNULATION OVER A PANCREATIC DUCT STENT TO REDUCE THE RATE OF PRECUT¿. THE PRIMARY OUTCOME WAS THE RATE OF SUCCESSFUL BILIARY CANNULATION WITHOUT PERFORMING A PRECUT SPHINCTEROTOMY. IF BILIARY CANNULATION IS UNSUCCESSFUL, THE PD IS CANNULATED AND A 0.025- OR 0.035-INCH GUIDEWIRE IS ADVANCED TO THE LEVEL OF THE MID PANCREATIC BODY TO ALLOW PLACEMENT OF A SOFT POLYETHYLENE STENT. THE TYPE OF STENT IS LEFT TO THE DISCRETION OF THE ENDOSCOPIST, EITHER A 4F (IF USING A 0.025-INCH WIRE) OR 5F STENT WITH AN EXTERNAL PIGTAIL AND SINGLE INTERNAL FLANGE (FREEMAN PANCREATIC STENT; HOBBS MEDICAL INC, STAFFORD SPRINGS, CONN) OR A 5F STENT WITH A DOUBLE EXTERNAL AND SINGLE INTERNAL FLANGE (GEENEN PANCREATIC STENT; COOK MEDICAL, BLOOMINGTON, IND). THE INTERNAL FLANGE IS OCCASIONALLY REMOVED TO PROMOTE SPONTANEOUS PASSAGE OF THE STENT AFTER THE PROCEDURE. A PANCREATIC SPHINCTEROTOMY WAS NOT PERFORMED BEFORE DEPLOYING THE PD STENT. THE STENT MAY BE DEPLOYED BY USING THE SPHINCTEROTOME AS A PUSHER. ONCE THE STENT IS ADVANCED TO ITS DESIRED POSITION, THE WIRE IS PULLED BACK INTO THE SPHINCTEROTOME AND ATTEMPTS AT BILIARY CANNULATION RESUME. PHYSICIAN-CONTROLLED WGC OF THE BILE DUCT IS THEN ATTEMPTED OVER THE PD STENT. IF CANNULATION IS UNSUCCESSFUL AFTER SEVERAL MINUTES, A PRECUT SPHINCTEROTOMY IS PER-FORMED OVER THE PD STENT OR THE PROCEDURE IS TERMINATED AND THE PATIENT RESCHEDULED FOR ANOTHER ATTEMPT. 5F GEENEN (COOK MEDICAL) (N = 31). THERE WERE 4 (5.3%) CASES OF MILD POST-ERCP PANCREATITIS, 2 OF WHICH OCCURRED IN PATIENTS WHO HAD THEIR PD STENT REMOVED AT THE COMPLETION OF THE PROCEDURE. THIS FILE IS ALSO RELATED TO OFF LABEL USE AS THE DEVICE WAS USED TO FACILITATE BILIARY CANNULATION & POTENTIALLY ALTERING THE SHAPE OF THE STENT "THE INTERNAL FLANGE IS OCCASIONALLY REMOVED TO PROMOTE SPONTANEOUS PASSAGE OF THE STENT AFTER THE PROCEDURE"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1072314 | GEENEN PANCREATIC STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention |