FDA.reportPublic FDA data

MAUDE MDR 1177462

MDR report key
1177462
Report number
2953161-2008-00278
Event key
0
Event type
3
Date of event
2008-03-13
Date received
2008-09-25
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
DANIELLE FAZIO
Address
3450 W. KILTIE LANE FLAGSTAFF AZ 86001 US
Phone
925-925-9258
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GORE EXCLUDER AAA ENDOPROSTHESISNONEW. L. GORE & ASSOCIATES, INC.MIHWLG325PXC14120005470107YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-09-2501. R

Event Narratives#

D

Patient 1

IN 2007, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. IN 2008, IMAGING REVEALED A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC AND LUMBAR ARTERIES. CONTRAST WAS ALSO OBSERVED OUTSIDE OF THE TRUNK IPSILATERAL LIMB IN THE RIGHT COMMON ILIAC ARTERY. IMAGES TAKEN ABOUT 2 MONTHS LATER, CONFIRMED THE ENDOLEAKS. A REINTERVENTION TOOK PLACE AT ABOUT 20 DAYS LATER USING AN ILIAC EXTENDER COMPONENT. NO FURTHER EVENTS WERE REPORTED.

N

Patient 1

A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. H6: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE SEE ATTACHED LIST OF ADDITIONAL DEVICES IMPLANTED IN THIS PT.