FDA.reportPublic FDA data

MAUDE MDR 740985

MDR report key
740985
Report number
2953200-2006-00167
Event key
0
Event type
3
Date of event
2006-06-27
Date received
2006-07-27
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
VIRANDER SINGH
Address
3576 UNOCAL PLACE SANTA ROSA CA 95403 US
Phone
707-707-7075
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEMAAA STENT GRAFTMEDTRONIC VASCULARNIHNAYRBRHXC2615165596236YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-07-2701. R

Event Narratives#

D

Patient 1

A 26 MM DIAMETER X 15 MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFTT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNK. IT WAS REPORTED THAT 8 MONTHS POST IMPLANT THE PT WAS IN FOR FOLLOW-UP APPOINTMENT. THE CT DEMONSTRATED THAT DUE TO BY DISEASE PROGRESSION RESULTING IN DILATATION OF THE AORTIC NECK THE STENT GRAFT HAS MIGRATED. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER MFR'S AORTIC CUFF. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

N

Patient 1

EVALUATION RESULTS - LACK OF INFO (NO OPERATION REPORTS OR FILMS ARE AVAILABLE). LACK OF EFFECTIVENESS RELATED TO PT CONDITION (DILATED AORTIC NECK).