EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
Report
- Report Number
- 3001845648-2023-00675
- Event Type
- Injury
- Date Received
- September 6, 2023
- Report Date
- January 17, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- ESW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) #K162717. CANCELLATION REPORT IS BEING SUBMITTED AS THE CONCLUSIONS OF THE INVESTIGATION HAVE BEEN SUBMITTED UNDER PR (B)(4) IN ORDER TO CAPTURE THE USE ERROR OF CLIP MARKING PRIOR TO STENT PLACEMENT AND THE RESULTING DEPLOYMENT FAILURE.
PMA/510(K) #: K162717. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
CANCELLATION REPORT IS BEING SUBMITTED AS THE CONCLUSIONS OF THE INVESTIGATION HAVE BEEN SUBMITTED UNDER PR (B)(4) IN ORDER TO CAPTURE THE USE ERROR OF CLIP MARKING PRIOR TO STENT PLACEMENT AND THE RESULTING DEPLOYMENT FAILURE.
DEVICE ISSUE: DEVICE RELATED ISSUE WITH WITHDRAWING INTRODUCER; STUDY DEVICE: RELATED, STUDY PROCEDURE: NO RESPONSE, PRE-EXISTING: NO RESPONSE; DEVICE DEFICIENCY: NO RESPONSE. FAILURE TO PLACE THE DEVICE AT THE INTENDED LOCATION - EXACT REASON NOT COMPREHENSIBLE, STENT DISLOCATED AFTER GUIDE-WIRE WAS REMOVED ; STENTEX ; CHANGED TO ANOTHER COMPANY. DEVICE RELATED ISSUE WITH WITHDRAWING INTRODUCER - ENDOSCOPIC TREATMENT TO PLACE NEW COMPETITOR STENT EVENT STATUS: RESOLVED; TREATMENT: ENDOSCOPIC NEW STENT PLACED (NON-STUDY), WALLFLEX; DEATH: NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1454755 | EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED | ESW PROSTHESIS, ESOPHAGEAL | ESW | COOK IRELAND LTD | C1515329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Required Intervention |