ZIMMON PANCREATIC STENT
Report
- Report Number
- 3001845648-2020-00709
- Event Type
- Malfunction
- Date Received
- October 1, 2020
- Report Date
- December 7, 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 ZIMMON 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 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 PR(B)(4), PR (B)(4), PR(B)(4), PR(B)(4), PR(B)(4) & PR(B)(4) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE PR(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) PR (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) PR(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) PR(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) PR (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) PR (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 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 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. AS PER INFORMATION REPORTED IN THE PAPER , 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. 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. 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 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. THIS USER ERROR WOULD BE CONSIDERED SECONDARY TO THE OFF-LABEL USE HOWEVER. 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.
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.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO UPDATES TO THE DESCRIPTION OF EVENTS: 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. THIS FILE WAS CREATED TO CAPTURE THE OFF LABEL USE OF THE ZIMMON (5FR, 4CM) PANCREATIC STENT, AS IT WAS PLACED PROPHYLACTICALLY. THE FOLLOWING ARE ALSO COVERED WITHIN THIS FILE, ALL RELATED TO OFF LABEL USE: 1. USER ERROR POTENTIAL USE OF 0.025INCH WIRE GUIDE. 2. STENT DISLODGEMENT- STENTS WERE PLACED PROPHYLACTICALLY WITH THE INTENTION TO SPONTANEOUSLY DISLODGE AS BOTH ZIMMON AND GEENEN DEVICES WERE USED AND WE CANNOT DETERMINE HOW MANY OF EACH DEVICE WAS USED, A SEPARATE FILE HAS BEEN CREATED TO CAPTURE THE GEENEN DEVICE. ADDITIONAL FILES HAVE ALSO BEEN CREATED TO CAPTURE ABDOMINAL PAIN AND HYPERAMYLASEMIA WHICH IS ASSOCIATED WITH OFF LABEL ALSO EXACT RPN CANNOT BE CONFIRMED, POTENTIAL RPN¿S ARE SPSOF-5-4, ZEPDF-5-4, ZEPDS-5-4 OR ZPSOF-5-4.
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. THIS FILE WAS CREATED TO CAPTURE THE OFF LABEL USE OF THE ZIMMON (5FR, 4CM) PANCREATIC STENT, AS IT WAS PLACED PROPHYLACTICALLY. THE FOLLOWING ARE ALSO COVERED WITHIN THIS FILE, ALL RELATED TO OFF LABEL USE: USER ERROR POTENTIAL USE OF 0.025INCH WIRE GUIDE. STENT DISLODGEMENT- STENTS WERE PLACED PROPHYLACTICALLY WITH THE INTENTION TO SPONTANEOUSLY DISLODGE. AS BOTH ZIMMON AND GEENEN DEVICES WERE USED AND WE CANNOT DETERMINE HOW MANY OF EACH DEVICE WAS USED, A SEPARATE FILE HAS BEEN CREATED TO CAPTURE THE GEENEN DEVICE. ADDITIONAL FILES HAVE ALSO BEEN CREATED TO CAPTURE ABDOMINAL PAIN AND HYPERAMYLASEMIA WHICH IS ASSOCIATED WITH OFF LABEL ALSO EXACT RPN CANNOT BE CONFIRMED, POTENTIAL RPN¿S ARE SPSOF-5-4, ZEPDF-5-4, ZEPDS-5-4 OR ZPSOF-5-4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1080317 | ZIMMON PANCREATIC STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male |