FDA Adverse Event
Malfunction
Summary report: N
EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
MDR report key: 24875043
·
Received April 14, 2026
Report
- Report Number
- 3001845648-2026-00142
- Event Type
- Malfunction
- Date Received
- April 14, 2026
- Date of Event
- February 26, 2026
- Report Date
- April 20, 2026
- Manufacturer
- COOK IRELAND LTD
- Product Code
- ESW
- UDI-DI
- 10827002480305
- PMA / PMN Number
- K162717
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
Description of Event or Problem · 0
ECHEC DE POSE TO BE CONFIRMED. CUSTOMER DID NOT ANSWER THE EMAILS FROM SSC AND SBU.BUT THEY TOLD THE SBU THAT THIS DEVICE WAS USED IN DECEMBER 202526-MAR-26: PROBLEM FOR THE STAFF WHO WERE UNABLE TO REMOVE THE PIN (GOUPILLE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21470 | EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED | ESW,PROSTHESIS, ESOPHAGEAL | ESW | COOK IRELAND LTD | G48030 | C2326064 | 10827002480305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |