FDA Adverse Event
Injury
Summary report: N
COVERED STENT
MDR report key: 4241130
·
Received November 5, 2014
Report
- Report Number
- 1219977-2014-00370
- Event Type
- Injury
- Date Received
- November 5, 2014
- Report Date
- October 28, 2014
- Product Code
- JCT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
WE ARE AWAITING ADDITIONAL DETAILS REGARDING THE INCIDENT AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE ADDITIONAL INFORMATION IS RECEIVED AND THE EVALUATION IS COMPLETED.
Description of Event or Problem · 1
REPORT RECEIVED STATED THAT A STENT MAY HAVE FRACTURED. NO OTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 711740 | COVERED STENT | JCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |