FDA.reportPublic FDA data

MAUDE MDR 817920

MDR report key
817920
Report number
2916596-2007-00025
Event key
0
Event type
3
Date of event
2007-01-04
Date received
2007-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ROBERT FRYC
Address
6035 STONERIDGE DRIVE PLEASANTON CA 94588 US
Phone
925-925-9258
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VECTRA VASCULAR ACCESS GRAFTVASCULAR ACCESS GRAFTTHORATEC CORP.DSYUNKUNKUNKYNR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-01-3101. R

Event Narratives#

D

Patient 1

THE PATIENT WAS IMPLANTED WITH A VASCULAR ACCESS GRAFT. IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING A GRAFT REVISION PROCEDURE, THE GRAFT THAT WAS REMOVED APPEARED TO BE SEPARATING AND DISINTEGRATING.

N

Patient 1

THE GRAFT WAS RETURNED TO THE MANUFACTURER AND IS CURRENTLY BEING EVALUATED. PRELIMINARY EXAMINATION REVEALED SOME UNUSUAL REVISION FEATURES. THE MANUFACTURER IS ATTEMPTING TO OBTAIN FURTHER DETAILS ON THE DEVICE AND THE REPORTED EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.