FDA Adverse Event
Injury
Summary report: N
CRYOVALVE
MDR report key: 191079
·
Received October 9, 1998
Report
- Report Number
- 1063481-1998-00030
- Event Type
- Injury
- Date Received
- October 9, 1998
- Date of Event
- April 20, 1998
- Report Date
- September 8, 1998
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MIE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SIX YEAR OLD MALE WITH MEDICAL HISTORY OF TETROLOGY OF FALLOT, DOUBLE OUTLET RIGHT VENTRICLE. SITUS INVERSUS, AORTIC VALVE CANAL DEFECT STATUS POST GLENN SHUNT AND PT DUCTUS ARTERIOSUS LIGATION UNDERWENT A RASTELLI PROCEDURE USING 18MM PULMONARY HOMOGRAFT WITH DACRON PROXIMAL EXTENSION. SUPERIOR VENA CAVA TO RIGHT ATRIUM CONDUIT REPAIR OF AORTIC VALVE CANAL DEFECT, AND GLENN SHUNT TAKEDOWN ON 02/21/1994. ON 04/20/1998 PT HAD VALVE EXPLANTED DUE TO OBSTRUCTION AT THE VENTRICULAR ATTACHMENT LEVEL. THE VALVE WAS REPLACED WITH A 24MM PULMONARY HOMOGRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYOVALVE Implant | HEART VALVE, ALLOGRAFT | MIE | CRYOLIFE, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Hospitalization| L| R |