FDA.reportPublic FDA data

MAUDE MDR 1101471

MDR report key
1101471
Report number
2017233-2008-00434
Event key
0
Event type
3
Date of event
2008-07-17
Date received
2008-08-06
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
ERIC STEMMLER
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 TAG THORACIC ENDOPROSTHESISNONEW.L. GORE & ASSOCIATESMIHWLG326TG311005897133YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-08-0601. R

Event Narratives#

D

Patient 1

AS REPORTED, IN 2008, THIS PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS. AT AN UNK DATE, IMAGING DEMONSTRATED THAT THE GRAFT HAD COLLAPSED. TWO MONTHS LATER, THE PT UNDERWENT A REINTERVENTION IN WHICH ANGIOPLASTY WAS PERFORMED AND THREE PALMAZ STENTS WERE IMPLANTED. PT IS IN STABLE CONDITION.

N

Patient 1

A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED.