EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
Report
- Report Number
- 3001845648-2017-00219
- Event Type
- Death
- Date Received
- June 9, 2017
- Date of Event
- October 24, 2016
- Report Date
- September 26, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- MUM
- UDI-DI
- 10827002480268
- PMA / PMN Number
- K101530
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
TWO DIFFERENT PMA/510(K) # LISTED: K163468. 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 AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. HOWEVER, THERE IS NOT SUFFICIENT INFORMATION TO CONCLUSIVELY DETEMINE IF THE COMPLAINT IS DEVICE RELATED OR NOT. AS THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF MANUFACTURING INSTRUCTIONS COULD NOT BE COMPLETE. PRIOR TO DISTRIBUTION, ALL EVO 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. THE NOTES SECTION OF INSTRUCTIONS FOR USE, POTENTIAL COMPLICATIONS SECTION: ¿THOSE ASSOCIATED WITH GI ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HAEMORRHAGE, ASPIRATION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST.¿ 10 DAYS AFTER THE PROCEDURE: THE PATIENT DIED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
TWO DIFFERENT PMA/510(K) # LISTED: K163468. 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 AS PER PRODUCT MANGER FEEDBACK: "I AM SEEING NOTHING FOR US TO DEFINITIVELY SAY THAT THE PERFORATION WAS CAUSED BY OUR DEVICE. IT COULD HAVE BEEN OUR DEVICE OR IT COULD HAVE BEEN THE SCOPE, THE WIRE GUIDE OR THE DISEASE." THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR RETURN TO COOK IRELAND FOR EVALUATION. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER DISCUSSION WITH ENGINEERING, PERFORATION IS A LISTED COMPLICATION AS PER THE IFU. IMAGING WAS PROVIDED FOR REVIEW ON 28 AUGUST 2017, THESE WERE DISCUSSED WITH CIRL ENGINEERING AND IT WAS DETERMINED THAT THERE WAS NO IMPACT TO THE OVERALL INITIAL INVESTIGATION CARRIED OUT. CIRL ENGINEER PROVIDED THE FOLLOWING FEEDBACK: "I NOTE THE STENT IS VISIBLE ON THE CT SCANS (CT # 2) IN A CURVED CONFIGURATION. THERE IS BLACK COLOUR EXTENDING FROM THE MIDDLE TO ONE END ¿ I AM PRESUMING THIS IS FREE AIR?" CLINICAL WERE CONTACTED AND PROVIDED THE FOLLOWING INPUT: "THE BLACK COLOUR EXTENDING ON CT IMAGE WAS FREE AIR." AS THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF MANUFACTURING INSTRUCTIONS COULD NOT BE COMPLETE. PRIOR TO DISTRIBUTION, ALL EVO 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. THE NOTES SECTION OF INSTRUCTIONS FOR USE, POTENTIAL COMPLICATIONS SECTION: ¿THOSE ASSOCIATED WITH GI ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HAEMORRHAGE, ASPIRATION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST.¿ 10 DAYS AFTER THE PROCEDURE: THE PATIENT DIED. QUALITY ENGINEERING ASSESSED THE COMPLAINT AS PER QSI0413 AND THE RISK HAS BEEN DETERMINED TO BE MODERATE (REF. (B)(4) REV 001). NO IMMEDIATE ACTION IS REQUIRED (RE (B)(4) REV 001 MODERATE RISK) COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510K: K101530. 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. A REVIEW OF THE QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ALL EVO 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. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS EVO-22-27-9-D LOT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT #; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
ON UNKNOWN DATE BETWEEN (B)(6) 2012 APPROX (B)(6) 2016 : EVOLUTION DUODENAL STENT WAS PLACED IN A (B)(6)-YEAR-OLD MALE PATIENT WHO HAD ADVANCED STOMACH CANCER WITH PYLORIC STENOSIS (CSTAGE IIIB). STENT PLACEMENT WAS SELECTED SINCE THE PHYSICIAN JUDGED THAT THE PATIENT WAS INOPERABLE DUE TO A BAD GENERAL CONDITION. SEVEN DAYS AFTER THE PROCEDURE: PATIENT'S CONDITION WAS IMPROVED AS MEASURED IN GOOSS SCORE OF 3. NINE DAYS AFTER THE PROCEDURE: THE PATIENT COMPLAINED ABOUT ACUTE ABDOMINAL PAIN, THEN DIAGNOSED WITH PERFORATION OF THE DIGESTIVE TRACT BY CT WHICH CONFIRMED SLIGHT FREE AIR AND MASS ASCITES FLUID. CONSERVATIVE TREATMENT WAS PERFORMED. TEN DAYS AFTER THE PROCEDURE: THE PATIENT DIED DESPITE CONSERVATIVE TREATMENT. ADDITIONAL INFORMATION IS PROVIDED ON 24/MAY/2017 ((B)(6)). AUTOPSY WAS NOT CONDUCTED. DESCRIPTION OF EVENT IS UPDATED/ CHANGED AS BELOW WITH ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2017 ((B)(6)). ON (B)(6) 2016 : EVOLUTION DUODENAL STENT ((B)(4)) WAS PLACED IN A (B)(6)-YEAR-OLD MALE PATIENT WHO HAD ADVANCED STOMACH CANCER WITH PYLORIC STENOSIS (CSTAGE IIIB). STENT PLACEMENT WAS SELECTED SINCE THE PHYSICIAN JUDGED THAT THE PATIENT WAS INOPERABLE DUE TO A BAD GENERAL CONDITION. SEVEN DAYS AFTER THE PROCEDURE: PATIENT'S CONDITION WAS IMPROVED AS MEASURED IN GOOSS SCORE OF 3. ON (B)(6) 2016 AT 23:00: THE PATIENT COMPLAINED ABOUT ACUTE ABDOMINAL PAIN. ON (B)(6) 2016: THE PATIENT WAS DIAGNOSED WITH PERFORATION OF THE DIGESTIVE TRACT BY CT WHICH CONFIRMED SLIGHT FREE AIR AND MASS ASCITES FLUID. CONSERVATIVE TREATMENT WITH ANTIBIOTICS WAS PERFORMED. HOWEVER, THE PATIENT DIED AT 23:00.
THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO IMAGE REVIEW. ON UNKNOWN DATE BETWEEN (B)(6) 2012 APPROXIMATELY (B)(6) 2016 : EVOLUTION DUODENAL STENT WAS PLACED IN A (B)(6)-YEAR-OLD MALE PATIENT WHO HAD ADVANCED STOMACH CANCER WITH PYLORIC STENOSIS (CSTAGE IIIB). STENT PLACEMENT WAS SELECTED SINCE THE PHYSICIAN JUDGED THAT THE PATIENT WAS INOPERABLE DUE TO A BAD GENERAL CONDITION. SEVEN DAYS AFTER THE PROCEDURE: PATIENT'S CONDITION WAS IMPROVED AS MEASURED IN GOOSS SCORE OF 3. NINE DAYS AFTER THE PROCEDURE: THE PATIENT COMPLAINED ABOUT ACUTE ABDOMINAL PAIN, THEN DIAGNOSED WITH PERFORATION OF THE DIGESTIVE TRACT BY CT WHICH CONFIRMED SLIGHT FREE AIR AND MASS ASCITES FLUID. CONSERVATIVE TREATMENT WAS PERFORMED. TEN DAYS AFTER THE PROCEDURE: THE PATIENT DIED DESPITE CONSERVATIVE TREATMENT. <ADDITIONAL INFORMATION IS PROVIDED ON (B)(6) 2017 ((B)(6))> - AUTOPSY WAS NOT CONDUCTED. <DESCRIPTION OF EVENT IS UPDATED/ CHANGED AS BELOW WITH ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2017 ((B)(6))> ON (B)(6) 2016 : EVOLUTION DUODENAL STENT ((B)(4)) WAS PLACED IN A (B)(6)-YEAR-OLD MALE PATIENT WHO HAD ADVANCED STOMACH CANCER WITH PYLORIC STENOSIS (CSTAGE IIIB). STENT PLACEMENT WAS SELECTED SINCE THE PHYSICIAN JUDGED THAT THE PATIENT WAS INOPERABLE DUE TO A BAD GENERAL CONDITION. SEVEN DAYS AFTER THE PROCEDURE: PATIENT'S CONDITION WAS IMPROVED AS MEASURED IN GOOSS SCORE OF 3. ON (B)(6) 2016 AT 23:00: THE PATIENT COMPLAINED ABOUT ACUTE ABDOMINAL PAIN. ON (B)(6) 2016: THE PATIENT WAS DIAGNOSED WITH PERFORATION OF THE DIGESTIVE TRACT BY CT WHICH CONFIRMED SLIGHT FREE AIR AND MASS ASCITES FLUID. CONSERVATIVE TREATMENT WITH ANTIBIOTICS WAS PERFORMED. HOWEVER, THE PATIENT DIED AT 23:00.
THIS "CORRECTION" MDR IS BEING SUBMITTED TO INCLUDE THE LOT# OF THE AFFECTED DEVICE WITHIN THE INVESTIGATION. THIS WAS OMITTED IN ERROR, THERE IS NO IMPACT ON THE INVESTIGATION RESULTS/FAILURE MODE AS A RESULT OF THIS OMISSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 411378 | EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED | MUM STENT, METALIC EXPANDABLE, DUODENAL | MUM | COOK IRELAND LTD | G48026 | 10827002480268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |