FDA Adverse Event
Injury
Summary report: N
CRYOVALVE
MDR report key: 191060
·
Received October 9, 1998
Report
- Report Number
- 1063481-1998-00027
- Event Type
- Injury
- Date Received
- October 9, 1998
- Date of Event
- August 25, 1997
- 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
THREE WEEK OLD FEMALE WITH MEDICAL HISTORY OF TRUNCUS ARTERIOSUS TYPE I UNDERWENT RIGHT VENTRICULAR OUTFLOW TRACT PROCEDURE USING A 9MM PULMONARY HOMOGRAFT ON 12/11/1995. ON 08/25/1997, PT HAD VALVE EXPLANTED DUE TO OUTGROWTH. OPERATIVE REPORT NOTES HOMOGRAFT WAS STILL PLIABLE AND NON-CALCIFIED. "JUST TOO SMALL." THE VALVE WAS REPLACED WITH AN 18MM 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 | 21 MO | Hospitalization| L| R |