MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-05 for PULMONARY VALVE & CONDUIT SG SGPV00 manufactured by Cryolife, Inc..
[88255646]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[88255647]
An email was received containing the following information: "cvor [cardio vascular operating room] coordinator mentioned that they had explanted an allograft pulmonary valve approx. 4 years after initial implant by [the surgeon]. Surgeon felt that this was earlier than expected failure of the valve. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00034 |
| MDR Report Key | 6915358 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-05 |
| Date of Report | 2017-10-04 |
| Date of Event | 2017-08-30 |
| Date Facility Aware | 2017-09-08 |
| Date Mfgr Received | 2017-09-08 |
| Device Manufacturer Date | 2011-07-26 |
| Date Added to Maude | 2017-10-05 |
| 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 | PULMONARY VALVE & CONDUIT SG |
| Generic Name | HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2017-10-05 |
| Model Number | SGPV00 |
| Catalog Number | SGPV00 |
| Lot Number | 113841 |
| Device Expiration Date | 2016-08-15 |
| Device Availability | N |
| 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. Hospitalization; 2. Other | 2017-10-05 |