FDA.reportPublic FDA data

MAUDE MDR 1673985

MDR report key
1673985
Report number
2017233-2010-00200
Event key
0
Event type
3
Date received
2010-04-30
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
GENEVIEVE BEGAY
Address
1500 N. FOURTH ST. FLAGSTAFF AZ 86004 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GORE TEX VASCULAR GRAFTDSY / PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETERW.L. GORE AND ASSOCIATESDSYWLG200R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-04-3001. R

Event Narratives#

D

Patient 1

IN 2001, PATIENT WAS IMPLANTED WITH A GORE-TEX VASCULAR GRAFT TO REPLACE HIS DISTAL AORTIC ARCH, PROXIMAL DESCENDING AORTA AND HIS PROXIMAL LEFT SUBCLAVIAN ARTERY TO REPAIR AN ANEURYSM THAT HAD FORMED AFTER HIS COARCTATION OF THE AORTA HAD BEEN REPAIRED IN CHILDHOOD. THE PREVIOUS ANEURYSM SAC HAD BEEN CLOSED OVER THE GRAFT. IT DEVELOPED AN EXPANSILE FLUID FILLED MASS AROUND THE GRAFT WHICH HAD STEADILY EXPANDED WITH NO EVIDENCE OF INFECTION AND NO EVIDENCE OF ABNORMAL FLOW. THIS EXPANSION CONTINUED UNTIL 2006, THE AREA WAS RE-EXPLORED THROUGH A FURTHER THORACOTOMY AND THE SPACE WAS DRAINED. THIS SLOWED THE EXPANSION DOWN. THE FLUID FILLED SAC HAS PROGRESSED FURTHER AND NOW OCCUPIES JUST UNDER HALF THE VOLUME OF THE CHEST CAVITY. PATIENT HAD CHRONICALLY COLLAPSED LEFT UPPER LOBE OF LUNG CAUSING "SEPSIS" WITHIN THE LUNG.

N

Patient 1

INVESTIGATION IS CURRENTLY IN PROGRESS.