FDA.reportPublic FDA data

MAUDE MDR 2103005

MDR report key
2103005
Report number
1063481-2011-00029
Event key
0
Event type
3
Date of event
2006-06-21
Date received
2011-05-25
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
MR. BRYAN BROSSEAU
Address
1655 ROBERTS BLVD. NW KENNESAW GA 30144 US
Phone
770-770-7704
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AORTIC VALVE AND CONDUIT SGHUMAN HEART VALVE ALLOGRAFTCRYOLIFE, INC.OHASGAV00*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-05-2501. R

Event Narratives#

D

Patient 1

INFORMATION REGARDING THE EXPLANT OF A SYNERGRAFT AORTIC VALVE AND CONDUIT ALLOGRAFT WAS OBTAINED THROUGH A RETROSPECTIVE CLINICAL STUDY. ACCORDING TO THE CLINICAL REPORT FORM, THE ALLOGRAFT WAS EXPLANTED APPROXIMATELY 5.5 YEARS AFTER IMPLANT DUE TO STRUCTURAL DETERIORATION, CALCIFICATION, VALVE LEAFLET DEGENERATION, INSUFFICIENCY, AND A TEAR OR PERFORATION OF VALVE LEAFLETS.

N

Patient 1

AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED AND THE RESULTS WILL BE REPORTED IN THE FINAL REPORT.

N

Patient 1

THE HEART VALVE WAS NOT RETURNED SO NO DIRECT OBSERVATIONS COULD BE MADE. A REVIEW OF PROCESSING RECORDS WAS PERFORMED AND INDICATES THAT THE ALLOGRAFT MET ALL SPECIFICATIONS. THE PRECISE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. 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.