GEENEN PANCREATIC STENT
Report
- Report Number
- 1037905-2018-00411
- Event Type
- Injury
- Date Received
- September 14, 2018
- Report Date
- August 22, 2018
- Manufacturer
- COOK ENDOSCOPY
- Product Code
- FGE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONTINUED FROM SECTION B3 DATE OF EVENT: 2009 LITERATURE ARTICLE CITATION: PRICE, L., BRANDABUR, J. J., KOZAREK, R. A., GLUCK, M., TRAVERSO, W. L., & IRANI, S. (2008). GOOD STENTS GONE BAD; ENDOSCOPIC TREATMENT OF PROXIMALLY MIGRATED PANCREATIC DUCT STENTS. GASTROINTESTINAL ENDOSCOPY, 67(5). DOI:10.1016/J.GIE.2008.03.998. CONTINUED FROM SECTION D2 COMMON NAME AND PRODUCT CODE: COMMON NAME-CATHETER, BILIARY, DIAGNOSTIC- PROCODE- 78FGE. CONTINUED FROM SECTION G5 PMA/510(K): K900923. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURE PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. PER THE PHOTO PROVIDED WE CANNOT COMPLETE A FULL EVALUATION. WITHOUT THE PRODUCT OR SUBSTANTIAL EVIDENCE TO CONTRADICT THE COMPLAINT, IT IS CONSIDERED CONFIRMED BASED SOLELY ON STATEMENTS DESCRIBING THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION; WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE PRODUCT LINES FOR GEENEN PANCREATIC STENTS WERE OBSOLETE IN 2010. THE INSTRUCTIONS FOR USE (IFU) STATES, "THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN." THE ARTICLE REPORTS, "THE AVERAGE TIME INTERVAL FROM STENT PLACEMENT TO MIGRATION DETECTION WAS 487 (S 367) DAYS". THE IFU WARNS, "THOSE [POTENTIAL COMPLICATIONS] ASSOCIATED WITH PANCREATIC STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE PANCREATIC TRACT OR DUODENUM, STENT MIGRATION." PRIOR TO DISTRIBUTION, ALL GEENEN PANCREATIC STENTS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME BECAUSE THE POTENTIAL MODEL NUMBERS WERE OBSOLETED JULY 22, 2010. THE GEENEN PANCREATIC STENTS ARE REMOVABLE IMPLANTABLE DEVICES WHERE THE IMPLANT TIME IS NO MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN AND A 3 YEAR EXPIRATION DATE THEREFORE ALL DEVICES DISTRIBUTED ARE BEYOND THEIR EXPECTED LIFE. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.
DURING MULTIPLE PANCREATICODUODENECTOMIES, THE PHYSICIAN(S) USED EIGHT (8) 3 FR COOK GEENEN PANCREATIC STENTS AS DESCRIBED IN THE BELOW EXCERPTS OF A CASE SERIES "DESIGN: CASE SERIES FROM A RETROSPECTIVE REVIEW OF ALL CASES OF UPSTREAM OR PROXIMALLY MIGRATED PANCREATIC DUCT STENTS, PLACED EITHER ENDOSCOPICALLY OR SURGICALLY, IDENTIFIED BETWEEN 2000 AND 2007. SURGICAL STENTS WERE PLACED IN THE PD [PANCREATIC DUCT] ANASTOMOSIS DURING SURGERY FOR THE FOLLOWING CONDITIONS: PANCREATIC CANCER (6), INTRADUCTAL PAPILLARY MUCINOUS NEOPLASM (3), AND CHOLEDOCHAL CYST (1). SURGICAL STENTS WERE STANDARD, SMALL, STRAIGHT, 3F, GEENEN STENTS (COOK MEDICAL, BLOOMINGTON IND). THE AVERAGE TIME INTERVAL FROM STENT PLACEMENT TO MIGRATION DETECTION WAS 487 (S 367) DAYS (1 OUTLIERCASE OMITTED). . . IN THE SURGICAL GROUP, STENT MIGRATION WAS DETECTED AFTER AN UNUSUALLY LONG PERIOD OF 12 YEARS. . . UNLIKE ENDOSCOPIC STENTS, ALL OF WHICH STAYED IN THE PD, MOST OF THE SURGICAL STENTS MIGRATED INTO THE BILIARY TREE (8 OF 10). ALL PATIENTS WERE SYMPTOMATIC WITH PAIN OR FEVER. NO SINGLE TECHNIQUE DOMINATED REMOVAL OF THESE STENTS. HOWEVER, CONTINGENT UPON LENGTH OF THE AFFERENT OR ROUX-EN-Y LIMB, A STANDARD DUODENOSCOPE OR PEDIATRIC COLONOSCOPE WAS USED TO ACCESS THE ANASTOMOSIS. THE SAME ENDOSCOPIC TOOLS WERE USED TO RETRIEVE THE STENTS (SUBJECT OF THIS REPORT). . .TWO STENTS COULD NOT BE RETRIEVED. ONE DUE TO EARLY PROCEDURE PERFORATION REQUIRING SURGICAL REPAIR OF THE JEJUNUM (SEE RELATED MDR 1037905-2018-00412) AND THE OTHER DUE TO UPSTREAM STENT MIGRATION INTO THE BILIARY ANASTOMOSIS (SEE RELATED 1037905-2018-00413). THIS PATIENT HAD A PERCUTANEOUS BILIARY DRAINAGE, STENT REMOVAL, AND FLEXUS EXPANDABLE STENT (CONMED, UTICA,NY) PLACEMENT THROUGH THE BILIARY ANASTOMOSIS." A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. THE PATIENTS WERE SYMPTOMATIC WITH PAIN OR FEVER. THE PATIENTS REQUIRED REMOVAL OF THE STENTS FROM THE BILE DUCT AS A RESULT OF THE STENT MIGRATING. NOTE: COOK ENDOSCOPY NO LONGER MANUFACTURES THE DEVICE.
DATE OF EVENT: 2009. LITERATURE ARTICLE CITATION: PRICE, L., BRANDABUR, J. J., KOZAREK, R. A., GLUCK, M., TRAVERSO, W. L., & IRANI, S. (2008). GOOD STENTS GONE BAD; ENDOSCOPIC TREATMENT OF PROXIMALLY MIGRATED PANCREATIC DUCT STENTS. GASTROINTESTINAL ENDOSCOPY, 67(5). DOI:10.1016/J.GIE.2008.03.998. COMMON NAME AND PRODUCT CODE: COMMON NAME-CATHETER, BILIARY, DIAGNOSTIC- PROCODE- 78FGE. PMA/510(K): K900923. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON THE INVESTIGATION COMPLETION. (B)(4).
DURING MULTIPLE PANCREATICODUODENECTOMIES, THE PHYSICIAN(S) USED EIGHT (8) 3 FR COOK GEENEN PANCREATIC STENTS AS DESCRIBED IN THE BELOW EXCERPTS OF A CASE SERIES. "DESIGN: CASE SERIES FROM A RETROSPECTIVE REVIEW OF ALL CASES OF UPSTREAM OR PROXIMALLY MIGRATED PANCREATIC DUCT STENTS, PLACED EITHER ENDOSCOPICALLY OR SURGICALLY, IDENTIFIED BETWEEN 2000 AND 2007. SURGICAL STENTS WERE PLACED IN THE PD [PANCREATIC DUCT] ANASTOMOSIS DURING SURGERY FOR THE FOLLOWING CONDITIONS: PANCREATIC CANCER (6), INTRADUCTAL PAPILLARY MUCINOUS NEOPLASM (3), AND CHOLEDOCHAL CYST (1). SURGICAL STENTS WERE STANDARD, SMALL, STRAIGHT, 3F, GEENEN STENTS (COOK MEDICAL, BLOOMINGTON IND). THE AVERAGE TIME INTERVAL FROM STENT PLACEMENT TO MIGRATION DETECTION WAS 487 (S Z 367) DAYS (1 OUTLIER CASE OMITTED). IN THE SURGICAL GROUP, STENT MIGRATION WAS DETECTED AFTER AN UNUSUALLY LONG PERIOD OF 12 YEARS. UNLIKE ENDOSCOPIC STENTS, ALL OF WHICH STAYED IN THE PD, MOST OF THE SURGICAL STENTS MIGRATED INTO THE BILIARY TREE (8 OF 10). ALL PATIENTS WERE SYMPTOMATIC WITH PAIN OR FEVER. NO SINGLE TECHNIQUE DOMINATED REMOVAL OF THESE STENTS. HOWEVER, CONTINGENT UPON LENGTH OF THE AFFERENT OR ROUX-EN-Y LIMB, A STANDARD DUODENOSCOPE OR PEDIATRIC COLONOSCOPE WAS USED TO ACCESS THE ANASTOMOSIS. THE SAME ENDOSCOPIC TOOLS WERE USED TO RETRIEVE THE STENTS (SUBJECT OF THIS REPORT). . .TWO STENTS COULD NOT BE RETRIEVED. ONE DUE TO EARLY PROCEDURE PERFORATION REQUIRING SURGICAL REPAIR OF THE JEJUNUM (SEE RELATED MDR 1037905-2018-00412) AND THE OTHER DUE TO UPSTREAM STENT MIGRATION INTO THE BILIARY ANASTOMOSIS (SEE RELATED 1037905-2018-00413). THIS PATIENT HAD A PERCUTANEOUS BILIARY DRAINAGE, STENT REMOVAL, AND FLEXUS EXPANDABLE STENT ((B)(6)) PLACEMENT THROUGH THE BILIARY ANASTOMOSIS." A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. THE PATIENTS WERE SYMPTOMATIC WITH PAIN OR FEVER. THE PATIENTS REQUIRED REMOVAL OF THE STENTS FROM THE BILE DUCT AS A RESULT OF THE STENT MIGRATING. NOTE: COOK ENDOSCOPY NO LONGER MANUFACTURES THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 718864 | GEENEN PANCREATIC STENT | FGE | COOK ENDOSCOPY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |