GEENEN PANCREATIC STENT SET
Report
- Report Number
- 3001845648-2019-00180
- Event Type
- Death
- Date Received
- May 2, 2019
- Report Date
- June 26, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K900923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)((B)(4)). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING AS FOLLOWS: (B)(4). (B)(4) SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE GEPD-X-X DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION GEPD-X-X 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. FOR THIS COMPLAINT AN RPN: GEPD-7-5 HAD BEEN ASSUMED, THIS WILL BE UPDATE ONCE CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS FOR GEPD-X-X OF UNKNOWN LOT NUMBER COULD NOT BE COMPLETED. THE INSTRUCTIONS FOR USE, IFU0055-3, WHICH ACCOMPANIES THIS DEVICE WARNS THE USER OF THE FOLLOWING POTENTIAL COMPLICATIONS ¿THOSE ASSOCIATED WITH PANCREATIC STENT PLACEMENT INCLUDE BUT ARE NOT LIMITED TO: TRAUMA TO THE PANCREATIC TRACT OR DUODENUM, OBSTRUCTION OF THE COMMON BILE DUCT, STENT MIGRATION.¿ THE INSTRUCTIONS FOR USE, IFU0055-3, PRECAUTIONS ¿THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED.¿ THE DESCRIPTION OF THE COMPLAINT STATES ¿AFTER A FEW MONTHS FROM PLACEMENT: THE STENT PERFORATED THE PANCREATIC DUCT CAUSING LEAKAGE OF PANCREATIC JUICE.¿ THE INSTRUCTION FOR USE, IFU0055-3 WARNS ¿THE TAPERED TIP END OF THE SENT MUST BE POSITIONED IN THE PANCREATIC DUCT WHILE THE OTHER END REMAINS IN THE DUODENUM.¿ THERE IS NOT ENOUGH EVIDENCE TO DETERMINE THAT THE CUSTOMER DID OR DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE (POSSIBLE): A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. OUR CLINICAL ADVISOR OUTLINED THE PATIENT¿S PRE-EXISTING CONDITION AND THE CAUSE OF DEATH WOULD BE NEEDED TO IDENTIFY IN ORDER UNDERSTAND IF THE PERFORATION OF THE STENT AGGRAVATE THE PATIENT¿S CONDITION AND WAS RELATED TO THE PATIENT DEATH. AS PER THE INSTRUCTIONS FOR USE, IFU0055-3, PRECAUTIONS ¿THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED.¿ THE DESCRIPTION OF THE COMPLAINT STATES ¿AFTER A FEW MONTHS FROM PLACEMENT: THE STENT PERFORATED THE PANCREATIC DUCT CAUSING LEAKAGE OF PANCREATIC JUICE¿. THE LENGTH OF THE INDWELL PERIOD NEEDS TO BE DETERMINED AS STENTS THAT EXCEED THE RECOMMENDED INDWELL PERIOD COULD CAUSE THE PERFORATION OF THE DUCT. OUR CLINICAL ADVISOR OUTLINES THAT PANCREATIC DUCT PERFORATION DUE TO STENT IS RARE, ESPECIALLY DELAYED PERFORATION. HOWEVER OTHER MEDICAL TREATMENTS THE PATIENT MAY BE RECEIVING OR RECEIVED MAY HAVE CAUSED THE SURROUNDING TISSUE TO BE WEAKENED RESULTING IN DETACHMENT OF THE STENT FROM THE WALL OF PANCREATIC DUCT. IN CONCLUSION THE FOLLOWING INFORMATION OF THE INDWELLING PERIOD OF THE STENT, THE STENT POSITION AND POSSIBLE CHEMORADIOTHERAPY RECEIVED BY THE PATIENT, THE PATIENT¿S PRE-EXISTING CONDITION AND CAUSE OF DEATH ARE CRUCIAL TO THE POSSIBLE ROOT CAUSE OF THIS STENT PERFORATION. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE FAILURE OF THIS DEVICE. HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THE INVESTIGATION WILL BE UPDATED IN THE FUTURE IF ANY ADDITIONAL INFORMATION IS RECEIVED. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPIRED. IT IS NOT CONFIRMED IF THIS WAS THE RESULT OF LEAKAGE OF STENT PERFORATION OR SOME OTHER PATIENT CONDITION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: ED SUTKOWSKI, COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA, 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)((B)(4)). EXEMPTION NUMBER: E2016031. (B)(4). (B)(4) SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DATE UNKNOWN: GPED-* STENT WAS PLACED. DATE UNKNOWN BUT AFTER A FEW MONTHS FROM PLACEMENT: THE STENT PERFORATED THE PANCREATIC DUCT CAUSING LEAKAGE OF PANCREATIC JUICE. DATE UNKNOWN: PATIENT EXPIRED.
DATE UNKNOWN: GPED-* STENT WAS PLACED. DATE UNKNOWN BUT AFTER A FEW MONTHS FROM PLACEMENT: THE STENT PERFORATED THE PANCREATIC DUCT CAUSING LEAKAGE OF PANCREATIC JUICE. DATE UNKNOWN: PATIENT EXPIRED.
DATE UNKNOWN: GPED - STENT WAS PLACED. DATE UNKNOWN BUT AFTER A FEW MONTHS FROM PLACEMENT: THE STENT PERFORATED THE PANCREATIC DUCT CAUSING LEAKAGE OF PANCREATIC JUICE. DATE UNKNOWN: PATIENT EXPIRED.
DATE UNKNOWN: GPED-* STENT WAS PLACED. DATE UNKNOWN BUT AFTER A FEW MONTHS FROM PLACEMENT: THE STENT PERFORATED THE PANCREATIC DUCT CAUSING LEAKAGE OF PANCREATIC JUICE. DATE UNKNOWN: PATIENT EXPIRED. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ BASED ON STENT PERFORATION CAUSING SERIOUS INJURY AND POSSIBILITY OF CAUSE OF DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 366533 | GEENEN PANCREATIC STENT SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |