MAUDE Adverse Event Report: CRYOLIFE, INC. CRYOVALVE SG AORTIC VALVE AND CONDUIT; HUMAN HEART VALVE

Model Number SGAV00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: CRYOVALVE SG AORTIC VALVE AND CONDUIT
• Type of Device: HUMAN HEART VALVE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144
• MDR Report Key: 6108986
• MDR Text Key: 60193842
• Report Number: 1063481-2016-00068
• Device Sequence Number: 1
• Product Code: OHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: SGAV00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/19/2016
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other