FDA.reportPublic FDA data

MAUDE MDR 3288878

MDR report key
3288878
Report number
2953161-2013-00109
Event key
0
Event type
3
Date of event
2012-09-18
Date received
2013-08-06
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
RACHAEL CHASCSA
Address
32470 N. NORTH VALLEY PARKWAY PHOENIX AZ 85085 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GORE EXCLUDER AAA ENDOPROSTHESISMIH / SYSTEM, ENDOVASCULAR GRAFT, ANEURYSM TREATMENTW. L. GORE & ASSOCIATESMIHPXT26141606706451R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-08-0601. R

Event Narratives#

D

Patient 1

ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT WAS BEING TRACKED EVERY THREE MONTHS POST OPERATIVE BY COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) FOR A PERSISTENT TYPE II ENDOLEAK. THERE WAS NO ANEURYSM GROWTH. ON (B)(6) 2010, THE PHYSICIAN IMPLANTED AN ADDITIONAL DEVICE (PXC181000/76816350) IN ATTEMPT TO TREAT THE TYPE II ENDOLEAK. THE PATIENT TOLERATED THE REINTERVENTION. THE TYPE II ENDOLEAK WAS STILL PRESENT, FEEDING FROM MULTIPLE COLLATERAL VESSELS. THE PHYSICAL PERFORMED A SECOND REINTERVENTION ON (B)(6), 2012, AND EXPLANTED ALL THE GORE EXCLUDER DEVICES. THE VASCULATURE WAS REPAIRED SURGICALLY AND THE PATIENT TOLERATED THE PROCEDURE.

N

Patient 1

ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: PXC141200/06823066 AND PXC181000/7681635. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK AND SURGICAL CONVERSION. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT.