GEENEN PANCREATIC STENT
Report
- Report Number
- 3001845648-2020-00740
- Event Type
- Injury
- Date Received
- October 2, 2020
- Date of Event
- November 20, 2004
- Report Date
- November 15, 2021
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K900923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
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 JOURNAL ARTICLE. COMPLAINTS (B)(4) WERE OPENED FROM THIS PAPER. THIS COMPLAINT WAS OPENED TO CAPTURE STENT OCCLUSION DUE TO OFF-LABEL USE IN 5 PATIENTS INVOLVING THE GEENEN PANCREATIC STENT (RPN: UNKNOWN). (B)(4) (3001845648-2020-00741) WAS OPENED TO CAPTURE OFF-LABEL USE IN 92 PATIENTS INVOLVING THE GEENEN PANCREATIC STENT (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. 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. IN THIS STUDY 97 PATIENTS WITH PD (PANCREATIC DUCT) DISRUPTION WERE IDENTIFIED AND UNDERWENT TRANPAPILLARY PD STENT INSERTION WITH A SUCCESS RATE OF 95% (92/97). A 0.035-INCH WIREGUIDE WAS INSERTED INTO THE PD AND A GEENEN PANCREATIC STENT (WILSON-COOK MEDICAL INC, WINSTON-SALEM, NC) WITH AN INTERNAL FLAP WAS INSERTED. WHEN A 3FR STENT WAS INSERTED, A SMALL CUT WAS MADE ON THE STENT TO CREATE AN INTERNAL FLAP. THE PD WAS CANNULATED WITH AN 0.018-INCH GUIDEWIRE WHEN THERE WAS AN EXTREMELY NARROW PD STRICTURE OR WHEN A 3FR STENT WAS PLACED. PANCREATOGRAPHY WAS OBTAINED IN ALL PATIENTS AT STENT REMOVAL, WHICH USUALLY WAS DONE 6 TO 8 WEEKS AFTER PLACEMENT. FOR A PERSISTENT LEAK, A NEW STENT WAS PLACED AND WAS EXCHANGED AT INTERVALS OF 6 TO 8 WEEKS. STENT OCCLUSION OCCURRED IN 5 PATIENTS WHERE THE STENT WAS OCCLUDED IN 3 PATIENTS WHEN IT WAS REMOVED AFTER 8 WEEKS. 1 OF THESE PATIENTS UNDERWENT A DISTAL PANCREATECTOMY. IN 2 OTHER PATIENTS WITH OCCLUDED STENTS, PUS WAS SEEN TO FLOW FROM THE PANCREATIC DUCT ORIFICE AT STENT REMOVAL AND BOTH PATIENTS UNDERWENT PANCREATIC DEBRIDEMENT. ACCORDING TO CLINICAL INPUT RECEIVED, THE GEENEN PANCREATIC STENT DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF A PATIENT WITH SEVERE ACUTE PANCREATITIS WHO DIED FROM MULTIORGAN FAILURE AFTER HAVING A PANCREATIC STENT INSERTED. 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. THE 5 PATIENTS THAT SUFFERED STENT OCCLUSION WERE AMONGST 97 PATIENTS THAT HAD GEENEN PANCREATIC STENTS INSERTED TO TREAT FISTULA AND THE 3FR STENT WAS ALTERED WHEN AN INCISION WAS MADE ON THE STENT TO CREATE AN INTERNAL FLAP, THIS IS REGARDED AS OFF-LABEL USE. IT MAY BE NOTED THAT STENT OCCLUSION IS LISTED AS A POTENTIAL COMPLICATION IN THE INSTRUCTIONS FOR USE (IFU0055-4) UNDER "OBSTRUCTION OF THE COMMON BILE DUCT". HOWEVER, IT MUST BE TAKEN INTO ACCOUNT THAT THESE STENTS WERE USED OFF-LABEL WHICH MAY HAVE BEEN AN INFLUENTIAL FACTOR ON THIS OCCLUSION. SUMMARY: COMPLAINT IS BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, 2 OF THE PATIENTS THAT SUFFERED STENT OCCLUSION WERE REPORTED TO BE DOING WELL FOLLOWING SURGERY WHILE ANOTHER HAD A PERCUTANEOUS DRAIN PLACED UNDER RADIOLOGICAL GUIDANCE FOR A PFC (PANCREATIC FLUID COLLECTIONS) COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
CORRECTION REPORT-UPDATES BELOW: STENT OCCLUSION (5 PATIENTS): IN 5 PATIENTS, THE STENT WAS OCCLUDED AT REMOVAL. IN TWO, THERE WAS RESOLUTION OF THE DUCT DISRUPTION, BUT PERSISTENT DISRUPTION IN THE OTHER 3 NECESSITATED SURGERY. IN 3 PATIENTS, THE PANCREATIC STENT WAS OCCLUDED AT REMOVAL 8 WEEKS LATER. IN ONE PATIENT WITH AN OCCLUDED STENT, THE DUCT LEAK (BODY OF PANCREAS) WAS STILL PRESENT AND A NEW LEAK HAD DEVELOPED IN THE REGION OF THE TAIL; DISTAL PANCREATECTOMY WAS PERFORMED, AND THE PATIENT WAS DOING WELL AT 6 MONTHS FOLLOW-UP. IN TWO OTHER PATIENTS WITH OCCLUDED STENTS, THE DUCT LEAK AT THE GENU HAD RESOLVED; BOTH WERE WELL AT THE 18 MONTHS¿ FOLLOW-UP. IN TWO PATIENTS, PUS WAS SEEN TO FLOW FROM THE PD ORIFICE AT STENT REMOVAL. BOTH HAD OCCLUDED STENTS (5F AND 7F, RESPECTIVELY); IN ONE, A PANCREATICOCUTANEOUS FISTULA WAS STILL PRESENT, AND, IN THE OTHER, THE DUCTAL LEAK IN THE BODY HAD WORSENED. BOTH PATIENTS UNDERWENT PANCREATIC DEBRIDEMENT. AT 3 MONTHS AFTER SURGERY, ONE PATIENT WAS DOING WELL AND THE OTHER HAD A PERCUTANEOUS DRAIN THAT WAS PLACED UNDER RADIOLOGIC GUIDANCE FOR A RECURRENT PFC.
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.
"VARADARAJULU ET AL 2005 (GEENEN PS) ¿ ¿PREDICTORS OF OUTCOME IN PANCREATIC DUCT DISRUPTION MANAGED BY ENDOSCOPIC TRANSPAPILLARY STENT PLACEMENT¿. ERCP WAS PERFORMED WITH THE PATIENT UNDER STANDARD CONSCIOUS SEDATION. UPON IDENTIFICATION OF THE PD DISRUPTION AS EXTRAVASATION OF CONTRAST INTO THE PFC, A 0.035-INCH GUIDEWIRE WAS INSERTED INTO THE PD AND A GEENEN PANCREATIC STENT (WILSON-COOK MEDICAL INC, WINSTON-SALEM, NC) WITH AN INTERNAL FLAP WAS INSERTED. WHEN A 3F STENT WAS PLACED, A SMALL CUT WAS MADE ON THE STENT TO CREATE AN INTERNAL FLAP. THE PD WAS CANNULATED WITH A 0.018-INCH GUIDEWIRE WHEN THERE WAS AN EXTREMELY NARROW PD STRICTURE OR WHEN A 3F STENT WAS PLACED. PANCREATOGRAPHY WAS OBTAINED IN ALL PATIENTS AT STENT REMOVAL, WHICH USUALLY WAS DONE 6 TO 8 WEEKS AFTER PLACEMENT. FOR A PERSISTENT LEAK, A NEW STENT WAS PLACED AND WAS EXCHANGED AT INTERVALS OF 6 TO 8 WEEKS. THE DIAMETERS OF THE PD STENTS USED WERE THE FOLLOWING: 3F (15%), 5F (45%), 7F (38%), AND 10F (2%). OFF LABEL USE: TO TREAT FISTULA. ALTERING THE 3 FR STENT (CUT TO ADD INTERNAL FLAP). STENT OCCLUSION: IN 3 PATIENTS, THE PANCREATIC STENT WAS OCCLUDED AT REMOVAL 8 WEEKS LATER. IN ONE PATIENT WITH AN OCCLUDED STENT, THE DUCT LEAK (BODY OF PANCREAS) WAS STILL PRESENT AND A NEW LEAK HAD DEVELOPED IN THE REGION OF THE TAIL; DISTAL PANCREATECTOMY WAS PERFORMED, AND THE PATIENT WAS DOING WELL AT 6 MONTHS¿ FOLLOW-UP. IN TWO OTHER PATIENTS WITH OCCLUDED STENTS, THE DUCT LEAK AT THE GENU HAD RESOLVED; BOTH WERE WELL AT THE 18 MONTHS¿ FOLLOW-UP. IN TWO PATIENTS, PUS WAS SEEN TO FLOW FROM THE PD ORIFICE AT STENT REMOVAL. BOTH HAD OCCLUDED STENTS (5F AND 7F, RESPECTIVELY); IN ONE, A PANCREATICOCUTANEOUS FISTULA WAS STILL PRESENT, AND, IN THE OTHER, THE DUCTAL LEAK IN THE BODY HAD WORSENED. BOTH PATIENTS UNDERWENT PANCREATIC DE-BRIDEMENT. AT 3 MONTHS AFTER SURGERY, ONE PATIENT WAS DOING WELL AND THE OTHER HAD A PERCUTANEOUS DRAIN THAT WAS PLACED UNDER RADIOLOGIC GUIDANCE FOR A RECURRENT PFC. THIS FILE WAS CREATED TO COVER THE 3 CASES OF STENT OCCLUSION AND IS ALSO RELATED TO OFF LABEL USE (PANCREATIC STENT USED TO TREAT FISTULA AND ALTERING THE 3 FR STENT (CUT TO ADD INTERNAL FLAP)).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1085993 | GEENEN PANCREATIC STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male | Required Intervention |