FDA Adverse Event
Other
Summary report: N
AORTIC VALVE AND CONDUIT
MDR report key: 1277425
·
Received November 11, 2008
Report
- Report Number
- 1063481-2008-00026
- Event Type
- Other
- Date Received
- November 11, 2008
- Report Date
- November 12, 2008
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MIE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
Description of Event or Problem · 1
ACCORDING TO THE REPORT, THE AORTIC VALVE WAS PROPERLY THAWED AND RINSED. A CRACK IN THE VALVE WAS NOTED. THE SURGEON WAS ABLE TO REPAIR THE CRACK AND THE VALVE WAS IMPLANTED WITH NO COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AORTIC VALVE AND CONDUIT | CRYOVALVE | MIE | CRYOLIFE, INC. | AV00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |