MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-02 for CRYOVALVE SG- PULMONARY VALVE AND CONDUIT SGPV00 manufactured by Cryolife, Inc..
[20324060]
(b)(6), cvor coordinator of (b)(6) hospital claimed that a pulmonary valve that was implanted fractured, but the surgeon repaired it.
Patient Sequence No: 1, Text Type: D, B5
[20505504]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[23536445]
(b)(6), cvor coordinator of (b)(6) hospital claimed that a pulmonary valve that was implanted fractured, but the surgeon repaired it. There is no indication that an error or deficiency occurred at cryolife. It is likely that the damage occurred at the user facility; cryolife personnel are trained to properly handle cryopreserved allografts and no errors or deficiencies were found in the processing record reviews. The instructions for use states, "cryopreserved allografts are fragile and must be handled with care while in the frozen state to avoid causing damage to the allograft" and "cardiac allografts are human biological tissues and, as such present considerable anatomical variation. Specific allograft attributes (representing normal variation) and donor-specific information is described in the allograft diagram and the certificate of assurance supplied with each allograft. "
Patient Sequence No: 1, Text Type: N, H10
[23536446]
(b)(6), cvor coordinator of (b)(6) hospital claimed that a pulmonary valve that was implanted fractured, but the surgeon repaired it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2014-00027 |
| MDR Report Key | 3910336 |
| Report Source | 06 |
| Date Received | 2014-07-02 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-06-23 |
| Date Mfgr Received | 2014-06-24 |
| Date Added to Maude | 2014-07-03 |
| 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 | SANDRA O'REILLY |
| 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- PULMONARY VALVE AND CONDUIT |
| Generic Name | HEART VALVE ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2014-07-02 |
| Model Number | SGPV00 |
| Lot Number | 10413223 |
| ID Number | DONOR: 128486 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2014-07-02 |