D
Patient 1
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.
MAUDE MDR 3935967
- MDR report key
- 3935967
- Report number
- 1063481-2014-00030
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-07-02
- Date received
- 2014-07-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- SANDRA O'REILLY
- Address
- 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US
- Phone
- 770-770-7704
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CRYOVALVE SG - AORTIC VALVE AND CONDUIT | HEART VALVE ALLOGRAFT | CRYOLIFE, INC. | OHA | SGAV00 | 7990860 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-07-15 | 0 | 1. O |
Event Narratives#
N
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
N
Patient 1
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.
D
Patient 1
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.