MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-04-10 for AORTIC VALVE AND CONDUIT SG SGAV00 manufactured by Cryolife, Inc..
[1143526]
The synergraft aortic valve was implanted on (b)(6)2003 and was explanted on (b)(6)2009, due to aortic stenosis.
Patient Sequence No: 1, Text Type: D, B5
[8325940]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063481-2009-00006 |
| MDR Report Key | 1359584 |
| Report Source | 05,06 |
| Date Received | 2009-04-10 |
| Date of Report | 2009-04-06 |
| Date of Event | 2009-04-02 |
| Date Mfgr Received | 2009-04-06 |
| Device Manufacturer Date | 2002-12-10 |
| Date Added to Maude | 2010-08-24 |
| 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., N.W. |
| 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 | AORTIC VALVE AND CONDUIT SG |
| Generic Name | HEART VALVE ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2009-04-10 |
| Returned To Mfg | 2009-04-06 |
| Model Number | SGAV00 |
| ID Number | 67402 (DONOR #) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | KENNESAW GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-04-10 |