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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 RLT351416
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 01/12/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Gore received the following information: on (b)(6) 2015, this patient underwent endovascular treatment for a thoracoabdominal aortic aneurysm measuring 87 mm in diameter and was treated with gore® excluder® aaa endoprostheses.On (b)(6) 2018, follow-up computed tomography imaging identified an aneurysm diameter of 99 mm and a proximal endoleak.On (b)(6) 2018, an additional stent was implanted below the superior mesenteric artery in an attempt to solve the endoleak.The patient tolerated the procedure.
 
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Brand Name
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key8524737
Report Number2017233-2019-00252
Device Sequence Number2689662
Product Code MIH
UDI-Device Identifier00733132618484
UDI-Public00733132618484
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
P020004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/20/2019
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
Operator of Device Health Professional
Device Expiration Date08/31/2017
Device Catalogue NumberRLT351416
Device Lot Number13035657
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age87 YR
Patient Weight62
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