MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,06 report with the FDA on 2011-05-25 for AORTIC VALVE AND CONDUIT SG SGAV00 manufactured by Cryolife, Inc..
[2143093]
Information regarding the explant of a synergraft aortic valve and conduit allograft was obtained through a retrospective clinical study. According to the clinical report form, the allograft was explanted approximately 5. 5 years after implant due to structural deterioration, calcification, valve leaflet degeneration, insufficiency, and a tear or perforation of valve leaflets.
Patient Sequence No: 1, Text Type: D, B5
[9055588]
An investigation into the reported event has been initiated and the results will be reported in the final report.
Patient Sequence No: 1, Text Type: N, H10
[9458917]
The heart valve was not returned so no direct observations could be made. A review of processing records was performed and indicates that the allograft met all specifications. The precise cause of the reported event cannot be determined with the available information. This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event. Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063481-2011-00029 |
| MDR Report Key | 2103005 |
| Report Source | 02,05,06 |
| Date Received | 2011-05-25 |
| Date of Report | 2011-05-19 |
| Date of Event | 2006-06-21 |
| Date Mfgr Received | 2011-04-20 |
| Device Manufacturer Date | 2000-05-18 |
| Date Added to Maude | 2011-05-26 |
| 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 | MR. BRYAN BROSSEAU |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AORTIC VALVE AND CONDUIT SG |
| Generic Name | HUMAN HEART VALVE ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2011-05-25 |
| Model Number | SGAV00 |
| Device Expiration Date | 2010-05-01 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-25 |