MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,06 report with the FDA on 2011-06-17 for AORTIC VALVE & CONDUIT SG SGAV00 manufactured by Cryolife, Inc..
[9476273]
According to the report, a reoperation was required on a patient who received an aortic valve and conduit sg allograft eight years after implant. The surgeon stated that the allograft was very calcified and it was not an easy procedure. The surgeon expressed concern with the amount of calcification that was seen eight years post-operatively. A review of processing records indicates that the allograft met all processing specifications prior to release. The events described in the report are consistent with structural valve deterioration. Structural valve deterioration is a known potential complication of human heart valve transplantation and has been frequently reported in the literature. The precise cause of the reported event is unknown; however, calcification is a known mode of failure for human heart valve allografts. Data has shown that calcification is more likely in pediatric patients than in adults. There is no evidence to suggest that there was an intrinsic problem with the valve prior to implant. No further action is recommended at this time. This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event. Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
Patient Sequence No: 1, Text Type: N, H10
[22232503]
According to the report, a reoperation was required on a patient who received an aortic valve and conduit sg allograft six years ago. The surgeon stated that the allograf was very calcified and it was not an easy procedure. The surgeon expressed concern with the amount of calcification that was seen six years post-operatively.
Patient Sequence No: 1, Text Type: D, B5
[22256931]
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Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063481-2011-00036 |
| MDR Report Key | 2132930 |
| Report Source | 02,06 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-06-17 |
| Date of Event | 2011-05-17 |
| Date Mfgr Received | 2011-05-17 |
| Date Added to Maude | 2011-06-20 |
| 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 | AORTIC VALVE & CONDUIT SG |
| Generic Name | HEART ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2011-06-17 |
| Model Number | SGAV00 |
| 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. Required No Informationntervention | 2011-06-17 |