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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Catalog Number RMT281416
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Code Available (3191)
Event Date 03/19/2015
Event Type  Injury  
Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak and aneurysm enlargement.
 
Event Description
The following was reported to gore: on (b)(6) 2013, the patient presented with an abdominal aortic aneurysm (diameter 55mm) that was treated with the implantation of gore® excluder® aaa endoprostheses.Follow-up imaging performed on (b)(6) 2015, showed aneurysm growth (diameter 58mm).On (b)(6) 2015, a proximal type i endoleak was identified and successfully treated with the implantation of an aortic extender endoprosthesis on (b)(6) 2015.The patient tolerated the procedure.
 
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Brand Name
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
Type of Device
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
joerg kersten
9285263030
MDR Report Key7657685
MDR Text Key112994304
Report Number2017233-2018-00363
Device Sequence Number1
Product Code MIH
UDI-Device Identifier00733132610723
UDI-Public00733132610723
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P020004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Physician
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2015
Device Catalogue NumberRMT281416
Device Lot Number10870320
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2012
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 Outcome(s) Required Intervention;
Patient Age77 YR
Patient Weight90
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