MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-02-26 for CRYOVALVE SG PULMONARY HUMAN HEART VALVE SGPV00 manufactured by Cryolife, Inc..
[16369142]
According to the report, the valve was implanted during a ross procedure performed in (b)(6) 2008 and was "good looking" approx one month after implant. Approx six months after implant, the valve developed "severe stenosis and degeneration".
Patient Sequence No: 1, Text Type: D, B5
[16502140]
The mfr's investigation into the reported event is ongoing. Any add'l info will be provided in the f/u report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063481-2009-00003 |
| MDR Report Key | 1375643 |
| Report Source | 05 |
| Date Received | 2009-02-26 |
| Date of Report | 2008-12-03 |
| Date Mfgr Received | 2008-12-03 |
| Date Added to Maude | 2010-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRYAN BROSSEAU, MGR |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOVALVE SG PULMONARY HUMAN HEART VALVE |
| Generic Name | HEART VALVE ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2009-02-26 |
| Model Number | SGPV00 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | KENNESAW GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-02-26 |