GEENEN PANCREATIC STENT
Report
- Report Number
- 3001845648-2020-00829
- Event Type
- Malfunction
- Date Received
- November 3, 2020
- Date of Event
- August 5, 2013
- Report Date
- November 15, 2021
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K900923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "USEFULNESS OF PANCREATIC DUCT WIRE-GUIDED ENDOSCOPIC PAPILLECTOMY FOR AMPULLARY ADENOMA FOR PREVENTING POST-PROCEDURE PANCREATITIS" (B)(4). 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. 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 PANCREATIC STENT WAS RE MOVED AT THE 7-DAY FOLLOW-UP DUODENOSCOPY IN THOSE PATIENTS WITHOUT EVIDENT PANCREATITIS. ACUTE PANCREATITIS OCCURRED IN 6/72 PATIENTS (8 %) AFTER ENDOSCOPIC PAPILLECTOMY. HOWEVER, PANCREATITIS WAS MILD IN ALL CASES AND RESOLVED WITH CONSERVATIVE MANAGEMENT. BLEEDING OCCURRED DURING THE PROCEDURE IN 12 PATIENTS (17 %), BUT IN ALL CASESWAS CONTROLLED WITH ENDOSCOPIC HEMOSTATIC METHODS. ROOT CAUSE REVIEW: 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 72 PATIENTS (41 MALE) WITH AMPULLARY ADENOMA UNDERWENT PANCREATIC DUCT WIRE-GUIDED ENDOSCOPIC PAPILLECTOMY AND HAD PANCREATIC STENTS (ZIMMON OR GEENEN - COOK MEDICAL) PLACED ALONG OR ALONGSIDE THE GUIDE WIRE. THIS WAS CARRIED OUT TO PREVENT POST-PROCEDURE PANCREATITIS OCCURRING WHICH IS REGARDED AS OFF LABEL USE AS THE DEVICE WAS USED PROPHYLACTICALLY. AS THE INFORMATION REPORTED THAT STENT MIGRATION DID NOT OCCUR IN 67/72 PATIENTS IT CAN BE CONCLUDED THAT 5 PATIENTS DID SUFFER STENT MIGRATION. IT MAY BE NOTED THAT STENT MIGRATION IS LISTED AS A POTENTIAL COMPLICATION IN THE IFU IN ASSOCIATION WITH PANCREATIC STENT PLACEMENT, HOWEVER, IT MUST BE TAKEN INTO ACCOUNT THAT THESE STENTS WERE USED OFF-LABEL WHICH MAY HAVE BEEN AN INFLUENTIAL FACTOR ON THIS MIGRATION. ACCORDING TO OUR CLINICAL ADVISER THE ACUTE PANCREATITIS THAT OCCURRED IN 6 PATIENTS DEVELOPED AFTER THE PROCEDURE OF ENDOSCOPIC PAPILLECTOMY AND WAS NOT STENT-RELATED WHILE THE BLEEDING THAT OCCURRED IN 12 PATIENTS OCCURRED DURING THE PROCEDURE OF ENDOSCOPIC PAPILLECTOMY AND NOT DURING THE PROCEDURE OF STENT PLACEMENT. SUMMARY: COMPLAINT IS BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED THE PANCREATIC STENT WAS REMOVED AT THE 7 DAY FOLLOW-UP DUODENOSCOPY IN THOSE PATIENTS WITHOUT EVIDENT PANCREATITIS. ACCORDING TO THE INFORMATION REPORTED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
ANNEX G: G04122 - STENT. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
ON 02-APR-21 CLINICAL ADVISOR HAS CONFIRMED THAT THE PAPER HAS IMPLIED THAT S SPONTANEOUS STENT MIGRATION OCCURRED IN 5 PATIENTS. FDA REPORTING PRECEDENCE EXISTS FOR 'STENT MIGRATION'. DESCRIPTION OF EVENT HAS BEEN UPDATED TO CAPTURE SPONTANEOUS STENT MIGRATION AS WELL AS OFF-LABEL USE PREVIOUSLY REPORTED. DESCRIPTION OF EVENT UPDATED BELOW: SHIN HEE KIM ET AL 2013 (GEENAN PANCTRATIC STENTS) ¿ ¿USEFULNESS OF PANCREATIC DUCT WIRE-GUIDED ENDOSCOPIC PAPILLECTOMY FOR AMPULLARY ADENOMA FOR PREVENTING POST-PROCEDURE PANCREATITIS¿. AIM: AFTER ENDOSCOPIC PAPILLECTOMY, PANCREATIC DUCT STENTING IS IMPORTANT IN PREVENTING PANCREATITIS, BUT DUCT CANNULATION CAN BE DIFFICULT FOLLOWING CONVENTIONAL SNARE RE-SECTION. PANCREATIC DUCT WIRE-GUIDED ENDOSCOPIC SNARING BEFORE RESECTION CAN REDUCE THE POST-PROCEDURE STENTING FAILURE RATE. WE EVALUATED THE USEFULNESS OF THIS APPROACH. PROCEDURE: AFTER SELECTIVE CANNULATION OF THE PANCREATIC DUCT, A 0.035-INCH GUIDE WIRE WAS INSERTED THROUGH THE CATHETER AND DEEP INTO THE PANCREATIC DUCT. AFTER THE EXCISION HAD BEEN COMPLETED, A 5-FR PANCRE-ATIC STENT (ZIMMON OR GEENEN STENT; WILSON-COOK MEDICAL INC, (B)(6) USA) WAS IMMEDIATELY INSERTED OVER THE GUIDE WIRE THAT HAD BEEN PREVIOUSLY PLACED IN THE PANCREATIC DUCT, AND WAS POSITIONED ACROSS THE PANCREATIC DUCT ORIFICE. THE LENGTH OF THE PANCREATIC DUCT STENT WAS CHOSEN SO THAT IT TRAVERSED THE GENU OF THE PANCREATIC DUCT. WHEN A RE-SECTED SPECIMEN WAS ATTACHED TO THE GUIDE WIRE, A SECOND GUIDE WIRE WAS INSERTED INTO THE PANCREATIC DUCT AND PLACED BESIDE THE FIRST, AS IN THE DOUBLE GUIDE WIRE TECHNIQUE [8]. IN THIS CASE, THE PANCREATIC STENT WAS INSERTED VIA THE SECOND GUIDE WIRE, AND THE FIRST GUIDE WIRE WAS REMOVED AFTER STENTING WAS COMPLETE. THE RESECTED SPECIMEN WAS IMMEDIATELY RETRIEVED FOR HISTOPATHOLOGIC EVALUATION. THE PANCREATIC STENT WAS RE-MOVED AT THE 7-DAY FOLLOW-UP DUODENOSCOPY IN THOSE PATIENTS WITHOUT EVIDENT PANCREATITIS. OFF LABEL USE: PROPHYLACTIC PLACEMENT OF A PANCREATIC STENT. AS PER ARTICLE: THERE WAS NO STENT MIGRATION IN 67 OF 72 (93 %) PATIENTS BEFORE ENDOSCOPIC REMOVAL AT THE 7-DAY FOLLOW-UP AFTER ENDOSCOPIC PAPILLECTOMY. AS PER ABOVE IT HAS BEEN NOTED THAT SPONTANEOUS STENT MIGRATION TOOK PLACE IN 5 PATIENTS WHO RECEIVED GENNEN PANCREATIC STENTS WHICH WERE USED OFF LABEL. THIS FILE WILL CAPTURE THE OFF-LABEL USE OF GENNEN PANCREATIC STENTS 5 OF WHICH SPONTANEOUSLY MIGRATED.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
THE BELOW DETAILS HAVE BEEN PROVIDED WITHIN THE PREVIOUSLY SUBMITTED MDR REPORT (3001845648-2020-00625). THROUGH THE COURSE OF THE CIRL INVESTIGATION IT WAS DECIDED TO CREATE 2 COMPLAINT FILES FOR BOTH POTENTIAL DEVICES (OF THE SAME COMMON NAME). NO CHANGE IN INFORMATION THAT WAS PREVIOUSLY SUBMITTED TO THE FDA. SHIN HEE KIM ET AL 2013 (GEENAN PANCTRATIC STENTS) ¿ ¿USEFULNESS OF PANCREATIC DUCT WIRE-GUIDED ENDOSCOPIC PAPILLECTOMY FOR AMPULLARY ADENOMA FOR PREVENTING POST-PROCEDURE PANCREATITIS¿. AIM: AFTER ENDOSCOPIC PAPILLECTOMY, PANCREATIC DUCT STENTING IS IMPORTANT IN PREVENTING PANCREATITIS, BUT DUCT CANNULATION CAN BE DIFFICULT FOLLOWING CONVENTIONAL SNARE RE-SECTION. PANCREATIC DUCT WIRE-GUIDED ENDOSCOPIC SNARING BEFORE RESECTION CAN REDUCE THE POST-PROCEDURE STENTING FAILURE RATE. WE EVALUATED THE USEFULNESS OF THIS APPROACH. PROCEDURE: AFTER SELECTIVE CANNULATION OF THE PANCREATIC DUCT, A 0.035-INCH GUIDE WIRE WAS INSERTED THROUGH THE CATHETER AND DEEP INTO THE PANCREATIC DUCT. AFTER THE EXCISION HAD BEEN COMPLETED, A 5-FR PANCRE-ATIC STENT (ZIMMON OR GEENEN STENT; WILSON-COOK MEDICAL INC, NORTH CAROLINA, USA) WAS IMMEDIATELY INSERTED OVER THE GUIDE WIRE THAT HAD BEEN PREVIOUSLY PLACED IN THE PANCREATIC DUCT, AND WAS POSITIONED ACROSS THE PANCREATIC DUCT ORIFICE. THE LENGTH OF THE PANCREATIC DUCT STENT WAS CHOSEN SO THAT IT TRAVERSED THE GENU OF THE PANCREATIC DUCT. WHEN A RE-SECTED SPECIMEN WAS ATTACHED TO THE GUIDE WIRE, A SECOND GUIDE WIRE WAS INSERTED INTO THE PANCREATIC DUCT AND PLACED BESIDE THE FIRST, AS IN THE DOUBLE GUIDE WIRE TECHNIQUE [8]. IN THIS CASE, THE PANCREATIC STENT WAS INSERTED VIA THE SECOND GUIDE WIRE, AND THE FIRST GUIDE WIRE WAS REMOVED AFTER STENTING WAS COMPLETE. THE RESECTED SPECIMEN WAS IMMEDIATELY RETRIEVED FOR HISTOPATHOLOGIC EVALUATION. THE PANCREATIC STENT WAS RE-MOVED AT THE 7-DAY FOLLOW-UP DUODENOSCOPY IN THOSE PATIENTS WITHOUT EVIDENT PANCREATITIS. OFF LABEL USE: PROPHYLACTIC PLACEMENT OF A PANCREATIC STENT. THIS FILE WILL CAPTURE THE OFF-LABEL USE OF GENNEN PANCREATIC STENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1246805 | GEENEN PANCREATIC STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male |