UNKNOWN
Report
- Report Number
- 3001845648-2019-00749
- Event Type
- Malfunction
- Date Received
- December 19, 2019
- Report Date
- April 25, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) #: AS THE RPN IS UNKNOWN, PROVIDING BOTH 510K NUMBERS FOR PARTIALLY AND FULLY COVERED EVOLUTION ESOPHAGEAL DEVICES K162717, K093619. DEVICE EVALUATION: THE EVO DEVICE OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. A TOTAL OF TWENTY FIVE PATIENTS WERE IDENTIFIED IN THIS RETROSPECTIVE STUDY OF 35 PROCEDURES OVER AN 8-YEAR PERIOD. THE STENTS USED WERE AS FOLLOWS: 11ENDOMAXX (MERIT), 11 WALLFLEX (BOSTON SCIENTIFIC), 5 POLYFLEX (BOSTON SCIENTIFIC), AND 3 EVOLUTION COOK ENDOSCOPY) WERE USED. THIS FILE CAPTURES STENT INFOLDING. DUE TO THE LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM IF THE EVO STENT'S USED WERE PARTIALLY/ FULLY COVERED AND USED FOR BENIGN OR MALIGNANT INDICATION. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO STENT IS UNKNOWN DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (PARTIALLY AND FULLY COVERED ESOPHAGEAL STENT) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0061-6, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. AS PER MEDICAL ADVISOR "STENT INFOLDING IS DUE TO POOR STENT APPOSITION TO THE WALL, THERE IS NO ¿STENT MALAPPOSITION¿ IN THE IFU, ¿STENT MISPLACEMENT¿ IN THE IFU IS THE CLOSEST ONE BUT THEY ARE NOT REALLY INTERCHANGEABLE. ¿STENT MALAPPOSITION¿ LIKELY OCCURS IN VASCULAR STENT, THAT IS THE REASON ¿STENT MALAPPOSITION¿ IS LISTED IN PTX IFU. I PRESUME THE INCIDENCE OF ¿STENT INFOLDING¿ IN GI TRACT WAS RARE, IT MIGHT BE THE REASON THAT ¿STENT INFOLDING¿ OR ¿STENT MALAPPOSITION¿ IS NOT CAPTURED IN IFU.". ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS PER MEDICAL ADVISOR: "I WOULD TEND TO BELIEVE THE STENT INFOLDING OCCURRED DURING THE PROCEDURE, AND DUE TO THE INFOLDING (STENT DOES NOT EXPAND FULLY),". HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN, AS NO DETAILS WERE GIVEN IN THE ARTICLE IN REGARD TO THE PROCEDURE USED TO MANAGE THE ¿STENT INFOLDING¿. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) #: AS THE RPN IS UNKNOWN, PROVIDING BOTH 510K NUMBERS FOR PARTIALLY AND FULLY COVERED EVOLUTION ESOPHAGEAL DEVICES K162717, K093619. DEVICE EVALUATION: THE EVO DEVICE OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE. A TOTAL OF TWENTY FIVE PATIENTS WERE IDENTIFIED IN THIS RETROSPECTIVE STUDY OF 35 PROCEDURES OVER AN 8-YEAR PERIOD. THE STENTS USED WERE AS FOLLOWS: 11ENDOMAXX (MERIT), 11 WALLFLEX (BOSTON SCIENTIFIC), 5 POLYFLEX (BOSTON SCIENTIFIC), AND 3 EVOLUTION COOK ENDOSCOPY) WERE USED. THIS FILE CAPTURES STENT INFOLDING. DUE TO THE LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM IF THE EVO STENT'S USED WERE PARTIALLY/ FULLY COVERED AND USED FOR BENIGN OR MALIGNANT INDICATION. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO STENT IS UNKNOWN DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (PARTIALLY AND FULLY COVERED ESOPHAGEAL STENT) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0061-6, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. AS PER MEDICAL ADVISOR "STENT INFOLDING IS DUE TO POOR STENT APPOSITION TO THE WALL, THERE IS NO ¿STENT MALAPPOSITION¿ IN THE IFU, ¿STENT MISPLACEMENT¿ IN THE IFU IS THE CLOSEST ONE BUT THEY ARE NOT REALLY INTERCHANGEABLE. ¿STENT MALAPPOSITION¿ LIKELY OCCURS IN VASCULAR STENT, THAT IS THE REASON ¿STENT MALAPPOSITION¿ IS LISTED IN PTX IFU. I PRESUME THE INCIDENCE OF ¿STENT INFOLDING¿ IN GI TRACT WAS RARE, IT MIGHT BE THE REASON THAT ¿STENT INFOLDING¿ OR ¿STENT MALAPPOSITION¿ IS NOT CAPTURED IN IFU." ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS PER MEDICAL ADVISOR: "I WOULD TEND TO BELIEVE THE STENT INFOLDING OCCURRED DURING THE PROCEDURE, AND DUE TO THE INFOLDING (STENT DOES NOT EXPAND FULLY)," HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN, AS NO DETAILS WERE GIVEN IN THE ARTICLE IN REGARD TO THE PROCEDURE USED TO MANAGE THE ¿STENT INFOLDING¿. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED DUE TO AN AMENDMENT TO THE LOT NUMBER DOCUMENTED IN SECTION D4.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION.
INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) #: AS THE RPN IS UNKNOWN, PROVIDING BOTH 510K NUMBERS FOR PARTIALLY AND FULLY COVERED EVOLUTION ESOPHAGEAL DEVICES K162717, K093619. FACILITIES REFERENCED IN THE LITERATURE: GASTROENTEROLOGY AND HEPATOLOGY, HUNTSMAN CANCER CENTER, UNIVERSITY OF UTAH SCHOOL OF MEDICINE, 30N 1900E 4R118, SALT LAKE CITY, UT 84132, USA. GASTROENTEROLOGY AND HEPATOLOGY, JEFFERSON UNIVERSITY SCHOOL OF MEDICINE, PHILADELPHIA, PA, USA.
COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 03DEC2019--DID 04DEC2019. AS REPORTED TO CUSTOMER RELATIONS: "ADVERSE EVENTS OCCURRED IN 6/14 (42.9%) PATIENTS WITH A MALIGNANT FISTULA AND IN 4/11 (36.4%) PATIENTS WITH A BENIGN FISTULA. 1 CASE OF STENT INFOLDING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1294486 | UNKNOWN | ESW PROSTHESIS, ESOPHAGEAL | FGE | COOK IRELAND LTD | UNKNOWN | ||
| 1294487 | UNKNOWN | ESW PROSTHESIS, ESOPHAGEAL | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |