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 SG AORTIC VALVE AND CONDUIT SGAV00 manufactured by Cryolife, Inc..
[2002374]
Information regarding the explant of a synergraft aortic valve and conduit allograft was obtained through a (b)(6) study. According to the clinical report form, the allograft was explanted approximately (b)(6) after implant due to unacceptable hemodynamics, calcification, and stenosis of valve.
Patient Sequence No: 1, Text Type: D, B5
[9077976]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[18419393]
Upon investigation, it was discovered that this represents a duplicate report. This event was previously investigated and reported to the fda (report number 1063481-2004-00012). An additional investigation was performed and the results are described below. The additional investigation does not change the conclusions reported in 1063481-2004-00012. 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
| Report Number | 1063481-2011-00032 |
| MDR Report Key | 2102962 |
| Report Source | 02,05,06 |
| Date Received | 2011-05-25 |
| Device Manufacturer Date | 2000-08-03 |
| 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 SG AORTIC VALVE AND CONDUIT |
| Generic Name | HUMAN HEART VALVE ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2011-05-25 |
| Model Number | SGAV00 |
| Device Expiration Date | 2010-08-01 |
| 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 |