MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-11 for CRYOVALVE SG - PULMONARY HEMI-ARTERY SG SGPH00 manufactured by Cryolife, Inc..
[4345645]
According to the report, the synergraft pulmonary hemi-artery seemed to be poor tissue quality. It bled "a ton" after sewing into the aortic arch. The repair stitches for the bleeding just further tore the tissue and a long segment of it looked blue, like it was so thin that you could see the blood beneath. The surgeon was able to stop the bleeding using many felt-augmented sutures.
Patient Sequence No: 1, Text Type: D, B5
[11553163]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[26263423]
According to the report, the synergraft pulmonary hemi-artery seemed to be poor tissue quality. It bled "a ton" after sewing into the aortic arch. The repair stitches for the bleeding just further tore the tissue and a long segment of it looked blue, like it was so thin that you could see the blood beneath. The surgeon was able to stop the bleeding using many felt-augmented sutures. The tissue was not returned to cryolife; therefore, no direct observations could be made. Processing records were reviewed and it was determined that the tissue met all specifications. No deficiencies were noted and there were no incident reports filed in the courier database during the transit/delivery of this package. The instructions for use includes adequate statements to explain that allografts are human biological tissue and present anatomical variation which is described on the allograft diagram and certificate of assurance supplied with the allograft.
Patient Sequence No: 1, Text Type: N, H10
[26263424]
According to the report, the synergraft pulmonary hemi-artery seemed to be poor tissue quality. It bled "a ton" after sewing into the aortic arch. The repair stitches for the bleeding just further tore the tissue and a long segment of it looked blue, like it was so thin that you could see the blood beneath. The surgeon was able to stop the bleeding using many felt-augmented sutures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2014-00007 |
| MDR Report Key | 3673090 |
| Report Source | 05,07 |
| Date Received | 2014-03-11 |
| Date of Report | 2014-03-01 |
| Date of Event | 2014-02-24 |
| Date Mfgr Received | 2014-03-01 |
| Device Manufacturer Date | 2013-03-28 |
| Date Added to Maude | 2014-03-11 |
| 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 HEMI-ARTERY SG |
| Generic Name | HEART ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2014-03-11 |
| Model Number | SGPH00 |
| Device Expiration Date | 2018-03-28 |
| Operator | PHYSICIAN |
| 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 | 2014-03-11 |