FDA.reportPublic FDA data

MAUDE MDR 997503

MDR report key
997503
Report number
2017233-2008-00066
Event key
0
Event type
3
Date received
2008-02-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
ROGER SMITH
Address
3250 W. KILTIE LANE 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 VIABAHN ENDOPROSTHESISNONEW.L. GORE & ASSOCIATES,INCJCTWLG335NNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-02-1201. R

Event Narratives#

D

Patient 1

DURING REVIEW OF A PUBLISHED ENDOVASCULAR STUDY, ("ENDOVASCULAR TREATMENT OF ASYMPTOMATIC POPLITEAL ANEURYSMS: 8-YR CONCURRENT COMPARISON WITH OPEN REPAIR," JOURNAL OF CARDIOVASCULAR SURGERY 2007, VOL 48, NUMBER 3, 275-9) A GORE VIABAHN ENDOPROSTHESIS WAS USED TO SEAL A POPLITEAL ANEURYSM. THE GRAFT WAS REPORTEDLY OVERSIZED BY ABOUT 20%, WHICH RESULTED AN INVAGINATION OF THE DEVICE. THIS WAS SUCCESSFULLY TREATED WITH INTRAOPERATIVE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND ADD'L PLACEMENT OF ANOTHER ENDOGRAFT. SEVENTY-TWO HRS POST IMPLANT, THE ENDOGRAFT OCCLUDED AND A OPEN SURGICAL REPAIR WAS PERFORMED. JOURNAL OF CARDIOVASCULAR SURGERY 2007, VOL 48, NUMBER 3, 275-9. AUTHOR - M. ANTONELLO, M.D. UNIV OF PADUA SCHOOL OF MEDICINE, VIA GIUSTINIANI 2, PADUA, ITALY.

N

Patient 1

DEVICE REMAINED IMPLANTED. NO INFO RELATED TO THE DEVICE IS AVAILABLE AT THIS TIME. THEREFORE, NO EVALUATION COULD BE PERFORMED.