FDA.reportPublic FDA data

MAUDE MDR 3125169

MDR report key
3125169
Report number
3007284313-2013-00034
Event key
0
Event type
3
Date of event
2013-04-29
Date received
2013-05-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CLAIRE WEST
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 ENDOPROSTHESISSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTW. L. GORE ASSOCIATESMIHPXC14140010774390Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-05-090

Event Narratives#

N

Patient 1

RESULTS: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

D

Patient 1

ON (B)(6) 2013, THE PT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE? EXCLUDER? AAA ENDOPROSTHESIS. AFTER A CONTRALATERAL LEG COMPONENT WAS ADVANCED INTO POSITION AND DEPLOYED, THE DELIVERY CATHETER COULD NOT BE WITHDRAWN. IT WAS REPORTEDLY NOTED THAT AFTER THE DEVICE WAS DEPLOYED, THE DELIVERY CATHETER WOULD NOT MOVE BACKWARDS ON THE AMPLATZ GUIDEWIRE, AND THE DELIVERY CATHETER APPEARED TO GET HUNG UP WHERE THE TRAILING OLIVE WAS CATCHING ON THE GORE DRY SEAL SHEATH. IT WAS REPORTED THAT AFTER FORCE WAS USED TO REMOVE THE DELIVERY CATHETER FROM THE PT, THE POLYIMIDE SHAFT BROKE OFF AT THE TRAILING OLIVE AND REMAINED IN THE PT. THE LEADING OLIVE WITH POLYIMIDE SHAFT WAS ABLE TO BE REMOVED WITH THE SHEATH, AND ANOTHER. SHEATH WAS ADVANCED TO CONCLUDE THE PROCEDURE. FINAL ANGIOGRAPHY SHOWED EXCLUSION OF THE ANEURYSM WITH NO DAMAGE TO THE PT'S ILIO-FEMORAL SYSTEM. THE PT TOLERATED THE PROCEDURE.