MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-15 for CRYOVALVE SG - AORTIC VALVE AND CONDUIT SGAV00 manufactured by Cryolife, Inc..
[4573866]
The sgav00 was implanted 11 years ago. The valve and graft were basically non visual, very difficult to distinguish and it was heavily calcified. The patient required a re-do procedure to replace the valve and root.
Patient Sequence No: 1, Text Type: D, B5
[12037145]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[37127846]
The sgav00 was implanted 11 years ago. The valve and graft were basically non visual, very difficult to distinguish and it was heavily calcified. The patient required a re-do procedure to replace the valve and root. Additional information was received which stated that "non-visual" meant it was difficult to distinguish leaflet anatomy. The patient did not have prior aortic valves or other tissue products implanted before the sg aortic valve. The valve was implanted as a root replacement and "very difficult to distinguish" was in respect to the conduit valve itself and not the patient's native tissue. The explanted allograft was returned for evaluation. The specimen consisted of multiple tan, yellow and gray fragments of vascular tissue measuring 8 x 10 cm in loose aggregate. Blue suture material was noted in multiple fragments. Several fragments were heavily calcified. Upon microscopic review, there was an abundance of calcification and infrequent focal areas of acute mild hemorrhage. There were also a few focal areas of mixed acute and chronic inflammation, which was predominantly chronic. The vascular wall was thickened and predominantly acellular. The valve leaflets were noted and showed large areas of calcific nodules. The occasional suture hole was also noted. Processing records were reviewed. All attributes noted during inspection were documented appropriately and the allograft met processing specification. A review was performed of the available information. The cryovalve aortic valve allograft was implanted via full root replacement and prior to valve implant the patient had never received any previous allograft tissue. Use of aortic allografts for aortic valve replacement is an excellent option for patients due to the excellent freedom from endocarditis, lack of anticoagulation therapies, being non-thrombogenic, and having superb hemodynamic characteristics. However, over time allografts can undergo calcification and structural valve deterioration (svd), and the valve may be explanted and replaced with another allograft or other aortic prosthesis. Structural valve deterioration is a known, commonly reported cause for valve-related reoperation and valve explant following aortic valve replacement with allograft and bioprosthetic valves. The durability of allograft valves has often been associated with patient age, as younger patients (< 65 years of age) have been reported to exhibit early svd and decreased durability versus older patients. However, the literature regarding the use cryopreserved aortic valve allografts for aortic valve replacement in young patients (< 65 years of age) that have produced favorable, long-term results in respect to freedom from reoperation, freedom from structural valve deterioration (svd), and freedom from explant due to svd. Freedom from explant due to svd in aortic allograft valves has been described in the literature, with several retrospective studies citing rates of 91%-97% at 10 years of follow-up. Similar to the patient in this reported event, the average patient age at time of implant was 53. 5 years old (range of 45-65 years old). According to the literature, explant of an aortic allograft due to structural valve deterioration and calcification 11 years after implantation in a 55 year old patient is not unexpected. Furthermore, histopathologic examination of the returned tissue showed "vascular aortic tissue with abundant calcification. " this finding is consistent with structural valve deterioration. The root cause of the reported event is unknown; however, given the duration of implantation, these findings are not unexpected.
Patient Sequence No: 1, Text Type: N, H10
[37127847]
The sgav00 was implanted 11 years ago. The valve and graft were basically non visual, very difficult to distinguish and it was heavily calcified. The patient required a re-do procedure to replace the valve and root.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2014-00030 |
| MDR Report Key | 3935967 |
| Report Source | 05,06 |
| Date Received | 2014-07-15 |
| Date of Report | 2014-07-01 |
| Date of Event | 2014-07-02 |
| Date Mfgr Received | 2014-07-01 |
| Date Added to Maude | 2014-07-15 |
| 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 - AORTIC VALVE AND CONDUIT |
| Generic Name | HEART VALVE ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2014-07-15 |
| Returned To Mfg | 2014-07-03 |
| Model Number | SGAV00 |
| Lot Number | 7990860 |
| ID Number | DONOR NUMBER 67095 |
| Device Expiration Date | 2012-11-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-07-15 |