EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
Report
- Report Number
- 3001845648-2023-00307
- Event Type
- Injury
- Date Received
- May 2, 2023
- Report Date
- November 2, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- ESW
- UDI-DI
- 10827002551708
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # K162717. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K162717. THIS FILE WAS CREATED FROM PMCF STUDY. THIS FILE IS RELATED TO (B)(4) (EMDR 3001845648-2023-00312). DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-FC-R-20-25-8-E OF LOT NUMBER C1568003 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: N/A. INSTRUCTIONS FOR USE AND/LABEL: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0067) STATES THE FOLLOWING: "THIS DEVICE IS USED TO MAINTAIN LUMINAL PATENCY OF THE ESOPHAGUS IN CASES OF: OBSTRUCTION CAUSED BY INTRINSIC OR EXTRINSIC MALIGNANCIES, REFRACTORY BENIGN STRICTURES, OR TO SEAL TRACHEOESOPHAGEAL FISTULAS." THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU OR LABEL. AS PER CASE STUDY THIS DEVICE WAS USED FOR "DEHISCENCE OF THE ESOPHAGEAL-JEJUNAL ANASTOMOSIS." IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. THE INFORMATION FOR USE STATES THAT THE DEVICE IS INTENDED FOR USE TO MAINTAIN LUMINAL PATENCY OF THE ESOPHAGUS IN CASES OF: OBSTRUCTION CAUSED BY INTRINSIC OR EXTRINSIC MALIGNANCIES, REFRACTORY BENIGN STRICTURES, OR TO SEAL TRACHEOESOPHAGEAL FISTULAS. HOWEVER FROM THE INFORMATION PROVIDED THE DEVICE WAS USED FOR TREATMENT OF AN ANASTOMOSIS , THIS IS CONSIDERED OFF LABEL USE. THE OFF LABEL USE MAY HAVE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENT OF STENT MIGRATION AS IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF ITS INTENDED USE. IT SHOULD ALSO BE NOTED THAT STENT MIGRATION IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, DEVICE ISSUES: STENT MIGRATION. CONFIRMED QUANTITY OF 01 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, PATIENTS OUTCOME WAS UNKNOWN. EVENT STATUS: EVENT ONGOING, TREATMENT: NO, DEATH: NO . INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY.
(B)(6) - DEVICE ISSUES: STENT MIGRATION. DEVICE ISSUE: NOT RELATED. DEVICE DEFICIENCY: NO. (B)(6) - 30 DAYS POST PLACEMENT: DISTAL STENT MIGRATION TO DISTAL JEJUNO CONFIRMED BY ENDOSCOPY. (B)(6) - 95 DAYS POST PROCEDURE: STENT MISPLACEMENT IN THE PELVIC AREA. EVENT STATUS: EVENT ONGOING. TREATMENT: NO. DEATH: NO.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 02-NOV-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1800136 | EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED | ESW PROSTHESIS, ESOPHAGEAL | ESW | COOK IRELAND LTD | C1568003 | 10827002551708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |