FDA.reportPublic FDA data

MAUDE MDR 529854

MDR report key
529854
Report number
2020394-2004-00057
Event key
0
Event type
3
Date of event
2004-04-14
Date received
2004-06-14
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
MARY EDWARDS
Address
1625 WEST 3RD ST. P.O. BOX 1740 TEMPE AZ 85280 US
Phone
480-480-4808
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VENAFLO EPTFE VASCULAR GRAFTEPTFE CUFFED AV ACCESS GRAFTBARD PERIPHERAL VASCULAR, INC.FIQ*UNK/VENAFLOUNKYRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-06-1401. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT SUBSEQUENT TO A FAILED CIMINO FISTULA IN THE ELBOW, A VENAFLO GRAFT WAS IMPLANTED IN THE LEFT LOWER ARM BETWEEN THE ANTECUBITAL ARTERY AND BASILIC VEIN. ONE YEAR AFTER IMPLANTATION, DUPLEX SONOGRAPHY SHOWED "MASSIVE CALCIFICATION" OF THE GRAFT. THEREFORE, PTA COULD NOT BE PERFORMED. A SURGICAL REVISION WAS PERFORMED, A 5CM SEGMENT OF "BRITTLE" GRAFT REMOVED, AND AN INTERPOSITION GRAFT WAS IMPLANTED. THE GRAFT OCCLUDED AGAIN. NINE DAYS LATER THE REMAINING "HARDENED" GRAFT WAS REPLACED.