FDA Adverse Event
Other
Summary report: N
PULMONARY VALVE AND CONDUIT SG
MDR report key: 1571865
·
Received December 15, 2009
Report
- Report Number
- 1063481-2009-00028
- Event Type
- Other
- Date Received
- December 15, 2009
- Date of Event
- December 11, 2009
- Report Date
- December 15, 2009
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MIE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADD'L INFO WILL BE PROVIDED IN THE F/U REPORT.
Description of Event or Problem · 1
ACCORDING TO THE REPORT, WHILE THE SYNERGRAFT PULMONARY VALVE AND CONDUIT WAS BEING IMPLANTED ONE OF THE VALVE LEAFLETS PROLAPSED BUT WAS REPAIRED. THE ALLOGRAFT REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULMONARY VALVE AND CONDUIT SG | HEART VALVE ALLOGRAFT | MIE | CRYOLIFE, INC. | SGPV00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |