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 CRYOVALVE AORTIC VALVE AND CONDUIT SG SGAV00 manufactured by Cryolife, Inc..
[9459482]
The allograft 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.
Patient Sequence No: 1, Text Type: N, H10
[16727023]
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 10 years after implant due to structural deterioration, calcification, valve leaflet degeneration, stenosis or obstruction of allograft valve and conduit.
Patient Sequence No: 1, Text Type: D, B5
[16938503]
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 | 1063481-2011-00030 |
| MDR Report Key | 2102955 |
| Report Source | 02,05,06 |
| Date Received | 2011-05-25 |
| Date of Report | 2011-05-19 |
| Date of Event | 2010-10-05 |
| Device Manufacturer Date | 2000-05-24 |
| 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 | CRYOVALVE 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 |