FDA.reportPublic FDA data

MAUDE MDR 415196

MDR report key
415196
Report number
2916596-2002-00037
Event key
0
Event type
3
Date of event
2002-03-07
Date received
2002-09-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
RAJAGOPAL KOWLIGI
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.DSY10002-6040-00110002-6040-001NIK001927YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-09-0601. R

Event Narratives#

D

Patient 1

PT DEVELOPED A STAPH. AUREUS INFECTION IN A VECTRA GRAFT PLACED IN A LOOP CONFIGURATION IN THE LEG. WHEN REMOVING THE INFECTED GRAFT, THE PHYSICIAN REPORTED THAT THE OUTER POROUS LAYER WAS NOT VISIBLE ON THE ENTIRE LENGTH OF THE GRAFT AND THE SUPPORT FIBERS WERE SURROUNDING THE SOLID MIDDLE LAYER OF THE GRAFT. BOTH SUTURE LINES WERE INTACT, AS THE SUTURES WERE SECURED IN THE SOLID MIDDLE LAYER OF THE GRAFT. THE PT WAS TREATED SUCCESSFULLY WITH ANTIBIOTICS AND WAS DIALYZED WITH A CATHETER.