MAUDE MDR 3415249

MDR report key
3415249
Report number
2017233-2013-00653
Event key
0
Event type
3
Date of event
2013-06-14
Date received
2013-10-04
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
DAMON JACKSON
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, AORTIC ANEURYSM TREATMENTW.L. GORE & ASSOCIATESMIHR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-10-0401. O

Event Narratives#

D

Patient 1

IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: CHARLES J. KEITH JR, BA, MARC A. PASSMAN, MD, MICHAEL J. GAFFUD, MD, ZDENEK NOVAK, MD, MSHI, BENJAMIN J. PEARCE, MD, THOMAS C. MATTHEWS, MD, MARK A. PATTERSON, MD, AND WILLIAM D. JORDAN JR, MD, "COMPARISON OF LONG-TERM OUTCOMES FOLLOWING ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS BASED ON SIZE THRESHOLD". COPYRIGHT 2013 BY THE SOCIETY FOR VASCULAR SURGERY. FROM JANUARY 2000 THROUGH DECEMBER 2011, 740 PATIENTS UNDERWENT ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS AT THE (B)(6) HOSPITAL, 383 (51.8%) OF WHOM WERE IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. THE MEAN AGE RANGED FROM 69.3 TO 73.6 YEARS. MORE THAN HALF OF THE PATIENTS WERE MALE. THE ARTICLE DESCRIBES THAT POST-OPERATIVE LIMB OBSTRUCTION WAS NOTED IN ONE PATIENT. THE ARTICLE DID NOT SPECIFY WHETHER THIS EVENT INVOLVED AN EXCLUDER DEVICE.