MAUDE MDR 1084656

MDR report key
1084656
Report number
2953161-2008-00190
Event key
0
Event type
3
Date of event
2008-05-29
Date received
2008-07-29
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 WEST KILTIE LANE FLAGSTAFF AZ 86001 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 & ASSOCIATESMIHWLG325PXT28141805789536YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-07-2901. R

Event Narratives#

D

Patient 1

AS REPORTED, IN 2008, THIS PT UNDERWENT ENDOVASCULAR REPAIR USING GORE EXCLUDER AAA ENDOPROSTHESES. THE PT PRESENTED WITH RIGHT LEG ISCHEMIA ABOUT 9 DAYS LATER. AN ANGIOGRAM REVEALED COMPRESSION OF THE IPSILATERAL LEG OF THE TRUNK IPSILATERAL LEG COMPONENT AND RIGHT ILIAC THROMBOSIS. THROMBOLYSIS WAS USED TO RESOLVE THE ISSUE, RESULTING IN A LEFT ARM HEMATOMA, DUE TO ANTICOAGULATIVE THERAPY. A REINTERVENTION OCCURRED 2 DAYS LATER, USING BOSTON SCIENTIFIC ULTRATHIN BALLOONS TO EXPAND THE DEVICE. AT APPROXIMATELY ONE WEEK LATER, A BOSTON SCIENTIFIC WALL STENT WAS IMPLANTED. THE PT IS REPORTEDLY DOING WELL.

N

Patient 1

A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.