FDA.reportPublic FDA data

MAUDE MDR 843785

MDR report key
843785
Report number
2017233-2007-00120
Event key
0
Event type
3
Date of event
2007-02-08
Date received
2007-05-01
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
HESTER GUNTHER
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 ENDOPROSTHESISENDOVASCULAR GRAFT SYSTEMW.L. GORE & ASSOCIATES,INCMIHPXT231212WLG32504711141YNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-05-0101. L

Event Narratives#

D

Patient 1

IN 2007, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS. THE PHYSICIAN SUCCESSFULLY DEPLOYED THE TRUNK-IPSILATERAL LEG COMPONENT. HE ATTEMPTED TO CANNULATE THE CONTRALATERAL GATE, BUT WAS NOT SUCCESSFUL. A DECISION WAS MADE TO CONVERT THE PATIENT TO AN AORTO UNI-ILIAC AND DO A FEMOROFEMORAL BYPASS. COMPLETION ANGIOGRAPHY SHOWED THAT BOTH RENAL ARTERIES WERE PATENT. FOLLOW-UP IMAGING REVEALED THAT THE RIGHT RENAL ARTERY WAS COVERED BY THE ENDOPROSTHESIS AND THAT BLOOD FLOW IS OCCLUDED. THE PATIENT IS ON DIALYSIS AS A RESULT OF THE COVERAGE OF THE RIGHT RENAL ARTERY. NO RE-INTERVENTION IS PLANNED.

N

Patient 1

DEVICE REMAINS IMPLANTED IN THE PATIENT. A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ALSO ASSOCIATED WITH THIS EVENT IS DEVICE.