MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-02-02 for CRYOVALVE SG AORTIC VALVE & CONDUIT SGAV00 manufactured by Cryolife, Inc. ? Kennesaw.
[66336873]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[66336874]
According to the report from the cryolife representative, "[the surgeon] asked me to come to his office to discuss the allograft sizing issues over the last 6 months. He has observed, and has documented, complete with angiograms of patients, that some of the smaller size av00's are becoming stenotic post operatively. In addition, he has observed that the smaller size av00's also appear to be shrinking postoperatively. He noted one incident where an implanted 9mm av00 was measured to be a 6mm postoperatively. I asked if someone from cryolife could contact him if they had more questions regarding these observations, and [the surgeon] said 'oh sure. ' [the surgeon] is concerned with the sizing issue that has occurred several times in the last 6 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00002 |
| MDR Report Key | 6295982 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-02-02 |
| Date of Report | 2018-03-09 |
| Date of Event | 2016-12-22 |
| Date Facility Aware | 2017-01-03 |
| Date Mfgr Received | 2017-01-03 |
| Date Added to Maude | 2017-02-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| 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 & CONDUIT |
| Generic Name | HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2017-02-02 |
| Model Number | SGAV00 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? KENNESAW |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-02 |