MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2016-11-17 for CRYOVALVE SG AORTIC VALVE AND CONDUIT SGAV00 manufactured by Cryolife, Inc..
[60193842]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[60193843]
According to the publication "late durability of decellularized allografts for aortic valve replacement: a word of caution" published in the journal of thoracic and cardiovascular surgery, assessment of the durability of dava [decellularized allografting] requires long-term follow-up. The authors reviewed patients who underwent arr with dava between 03/12/2002 and 10/06/2004 at mayo clinic, rochester, mn and missouri baptist medical center, st. Louis, mo. They compared outcomes between those patients and patients who underwent arr with a standard cryopreserved allograft during the same period. The primary outcome was reoperation, and the secondary outcome was survival. Forty-two patients underwent arr with a dava. Aortic valve reoperation was required in 37% of the survivors (15 of 41). Indications were endocarditis (n=11), aortic valve regurgitation associated with aortic aneurysm (n=5), isolated aortic valve regurgitation (n=13), aortic valve stenosis (n=12), and aortic dissection causing aortic valve regurgitation (n=1). Additionally, in the explanted davas, fibrosis and calcification were seen, with only minimal recellularization in the minority of cases.
Patient Sequence No: 1, Text Type: D, B5
[71114875]
According to the publication "late durability of decellularized allografts for aortic valve replacement: a word of caution" published in the journal of thoracic and cardiovascular surgery, assessment of the durability of dava [decellularized allografting] requires long-term follow-up. The authors reviewed patients who underwent arr with dava between 03/12/2002 and 10/06/2004 at (b)(6). They compared outcomes between those patients and patients who underwent arr with a standard cryopreserved allograft during the same period. The primary outcome was reoperation, and the secondary outcome was survival. Forty-two patients underwent arr with a dava. Aortic valve reoperation was required in 37% of the survivors (15 of 41). Indications were endocarditis (n=11), aortic valve regurgitation associated with aortic aneurysm (n=5), isolated aortic valve regurgitation (n=13), aortic valve stenosis (n=12), and aortic dissection causing aortic valve regurgitation (n=1). Additionally, in the explanted davas, fibrosis and calcification were seen, with only minimal recellularization in the minority of cases. Multiple attempts were made to obtain additional information from the author of the publication, including serial numbers of the cryolife decellurized valves used in the study, intervention and/or operative notes for the 15 patients who required reoperation, information regarding patient co-morbidities, dates of implant of each of the cryolife decellurized valves and dates of reoperation, and the current status of each patient; however, all attempts were unsuccessful. A review was performed of the available information. The authors state that 10-year patient survival was better for the dava vs. Standard group (76% vs. 57%, p=. 09). The mean age of the dava group was 49 years, however, the mean age of the standard group was not provided. In addition, the authors attributed the decreased survival of the control due to older patient age. Although the authors state there was a reduced freedom from reoperation at 10-years in the dava vs. Standard groups, this did not reach statistical significance (51%vs. 80%, p=. 06). Therefore, both the differences in survival and freedom from reoperation between the dava and standard groups were not statistically significant. Based on pathologic studies, the authors reported the mechanism of valve failure to be similar between the 2 groups, consisting of fibrosis and calcification. Because of the small patient populations in both groups (42 dava, 24 standard), and the lack of statistical significance in patient outcomes (survival and freedom from reoperation), it is difficult to draw any definitive conclusions from the data presented in this study. The sg aortic valve has not been produced by cryolife in >10 years. 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 (>65 years of age; dagneis 2005, doty 1998, smedira 2006). Because of the small patient populations in both groups and the lack of statistical significance in patient outcomes it is difficult to draw any definitive conclusions from the data presented in this study. The ifu indicates: "cryovalve sg aortic is human biological tissue and, as such, presents considerable anatomical variation. Specific valve attributes (representing normal biological variation) and donor-specific information are described in the allograft diagram on the certificate of assurance supplied with each valve. " the ifu lists degeneration as a potential adverse event that may occur with the use of cardiac allografts.
Patient Sequence No: 1, Text Type: N, H10
[71114876]
According to the publication "late durability of decellularized allografts for aortic valve replacement: a word of caution" published in the journal of thoracic and cardiovascular surgery, assessment of the durability of dava [decellularized allografting] requires long-term follow-up. The authors reviewed patients who underwent arr with dava between 03/12/2002 and 10/06/2004 at (b)(6). They compared outcomes between those patients and patients who underwent arr with a standard cryopreserved allograft during the same period. The primary outcome was reoperation, and the secondary outcome was survival. Forty-two patients underwent arr with a dava. Aortic valve reoperation was required in 37% of the survivors (15 of 41). Indications were endocarditis (n=11), aortic valve regurgitation associated with aortic aneurysm (n=5), isolated aortic valve regurgitation (n=13), aortic valve stenosis (n=12), and aortic dissection causing aortic valve regurgitation (n=1). Additionally, in the explanted davas, fibrosis and calcification were seen, with only minimal recellularization in the minority of cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2016-00068 |
| MDR Report Key | 6108986 |
| Report Source | LITERATURE |
| Date Received | 2016-11-17 |
| Date of Report | 2017-03-15 |
| Date Facility Aware | 2016-10-19 |
| Date Mfgr Received | 2016-10-19 |
| Date Added to Maude | 2016-11-17 |
| 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 | MS. 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 | CRYOVALVE SG AORTIC VALVE AND CONDUIT |
| Generic Name | HUMAN HEART VALVE |
| Product Code | OHA |
| Date Received | 2016-11-17 |
| 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. Other | 2016-11-17 |