FDA.reportPublic FDA data

MAUDE MDR 1165672

MDR report key
1165672
Report number
2017233-2008-00621
Event key
0
Event type
3
Date of event
2008-08-22
Date received
2008-09-18
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
ERIC STEMMLER
Address
3450 WEST 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 & ASSOCIATESMIHWLG325PXT31141706186235NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-09-1801. O

Event Narratives#

D

Patient 1

AS REPORTED, IN 2008, THIS PT UNDERWENT ENDOVASCULAR REPAIR USING GORE EXCLUDER AAA ENDOPROSTHESES. THE PT'S LEFT COMMON ILIAC ARTERY WAS PERFORATED BY A AMPLATZ SUPER-STIFF GUIDEWIRE DURING ACCESS. THREE DEVICES GORE EXCLUDER AAA ENDOPROSTHESES WERE IMPLANTED TO RESOLVE THE TEAR. WHILE ADVANCING A GORE EXCLUDER AAA ENDOPROSTHESIS IN THE PT'S RIGHT SIDE, THE RIGHT COMMON ILIAC ARTERY PERFORATED. THE PT WAS CONVERTED TO A UNPLANNED AORTOUNIILIAC. A TRUNK IPSILATERAL LEG COMPONENT WAS INSERTED INTO THE SHEATH ON THE PT'S LEFT SIDE. KINKING IN THE SHEATH PREVENTED THE DEVICE FROM BEING ADVANCED. BOTH THE DEVICE AND THE SHEATH WERE REMOVED SIMULTANEOUSLY AND THE PT WAS CONVERTED TO OPEN REPAIR. THE PT LOST APPROX 8 UNITS OF BLOOD DURING THE PROCEDURE. THE PT IS REPORTED TO BE STABLE AT THIS TIME.

N

Patient 1

A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.