FDA Adverse Event
Injury
Summary report: N
ESOPHACOIL TM ENDOPROSTHESIS
MDR report key: 349315
·
Received August 28, 2001
Report
- Report Number
- 2134479-2001-00001
- Event Type
- Injury
- Date Received
- August 28, 2001
- Report Date
- August 23, 2001
- Manufacturer
- SULZER INTRATHERAPEUTICS, INC.
- Product Code
- ESW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
2000: FIRST ESOPHACOIL STENT IMPLANT FOR CANCER OF ESOPHAGUS. 11/2000: REPORT TO DISTRIBUTOR THAT STENT FRACTURED IN 2 PIECES. ONE REMAINED IN THE ESOPHAGUS AND ONE PIECE MIGRATED INTO STOMACH. ONLY MEDICAL ACTION DETAILED IS NEW STENT TO BE PLACED. 11/2000: REPORT FROM DISTRIBUTOR TO MANUFACTURER. 2001: DISTRIBUTOR REPORTED SECOND PLACE STENT ALSO FRACTURED IN TWO LOCATIONS. 10 MONTHS POST IMPLANT PT HAD DIED FROM PNEUMONIA. 8/2001: REPORT BY PHYSICIAN TO MDA THAT PT HAD EMERGENCY SURGERY TO REMOVE STENT PIECE THAT HAD MIGRATED FROM STOMACH INTO BOWL CAUSING OBSTRUCTION AT AN INGUINAL HERNIA. PHYSICIAN STATES, "PATIENT ON ANTIREFLUX THERAPY SINCE STENT PLACEMEN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39235 | ESOPHACOIL TM ENDOPROSTHESIS | IMPLANTABLE ESOPHAGEAL STENT | ESW | SULZER INTRATHERAPEUTICS, INC. | EG-18-15-SR | P2833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention | PART OF 1ST STENT RETURNED, SECOND PENDING. |