MAUDE MDR 1096486

MDR report key
1096486
Report number
2953161-2008-00194
Event key
0
Event type
3
Date received
2008-08-04
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
1327 ORLEANS DR. SUNNYVALE CA 94089 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GORE EXCLUDER AAA ENDOPROSTHESISNONEW. L. GORE & ASSOCIATESMIHWLG325PXL16100705606116YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-08-0401. R

Event Narratives#

D

Patient 1

AS REPORTED, IN 2008, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT INFRARENAL ABDOMINAL AORTIC AND COMMON ILIAC ARTERY ANEURYSMS. THE INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AT THE BIFURCATION SITE OF THE INTERNAL ILIAC ARTERY AND EXTERNAL ILIAC ARTERY WAS PERFORMED IN ADVANCE. THE ACCESS SITE HEALED POORLY AND ON AN UNK DATE, AN INFECTION WAS IDENTIFIED WHICH EXTENDED TO THE SURROUNDINGS OF THE DEVICE. ALL DEVICES WERE REMOVED AND A VASCULAR GRAFT REPLACEMENT WAS PERFORMED. THE PHYSICIAN SUSPECTED THAT THE GORE EXCLUDER AAA ENDOPROSTHESES MAY NOT HAVE BEEN THE CAUSE OF THE INFECTION, AND THAT THE PT'S FEMORAL ARTERY WAS INFECTED PRIOR TO THE PROCEDURE. THE EXPLANTED DEVICES ARE NOT BEING RETURNED TO GORE.

N

Patient 1

A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.