Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE EXCLUDER AAA ENDOPROSTHESIS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

W.L. GORE & ASSOCIATES GORE EXCLUDER AAA ENDOPROSTHESIS Back to Search Results
Catalog Number RMT231416
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2014
Event Type  malfunction  
Event Description
On (b)(6) 2014, the patient was treated for abdominal aortic aneurysm using a gore excluder aaa endoprosthesis featuring gore c3 delivery system.The aorta was tortuous.Proximal aortic neck angulation was more than 100 degree.Trunk-ipsilateral leg endoprosthesis was implanted and deployed successfully.When opening the ipsilateral leg, the olive was still visible on the angiogram.The removed delivery catheter was screened and there the olive was pulled off.The olive was removed with a snare.The patient tolerated the procedure.
 
Manufacturer Narrative
Results: the review of the packaging paperwork verified that this lot met all pre-release specifications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GORE EXCLUDER AAA ENDOPROSTHESIS
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer Contact
eva steier
3750 w. kiltie ln
flagstaff, AZ 86005
9285263030
MDR Report Key3650515
MDR Text Key4352429
Report Number2017233-2014-00016
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P020004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2016
Device Catalogue NumberRMT231416
Device Lot Number11838659
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/08/2014
Initial Date FDA Received01/15/2014
Date Device Manufactured10/08/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age84 YR
-
-