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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE EXCLUDER AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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W. L. GORE & ASSOCIATES, INC. GORE EXCLUDER AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number RLT311415
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/23/2020
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2016, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore excluder aaa endoprosthesis.On (b)(6) 2020, it was noted during follow up that the trunk-ipsilateral leg component had migrated distally due to disease progression.No endoleak was noted, as the proximal end of the trunk-ipsilateral leg component was opposed against thrombus in the aortic neck.On the same day, a reintervention occurred whereby another trunk-ipsilateral leg component was implanted inside the previously implanted device.The device was implanted proximally in order to secure appropriate aortic seal.The patient tolerated the procedure.
 
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Brand Name
GORE EXCLUDER AAA ENDOPROSTHESIS
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
MDR Report Key10302425
Report Number3007284313-2020-01009
Device Sequence Number11476374
Product Code MIH
UDI-Device Identifier00733132619085
UDI-Public00733132619085
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/21/2020
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 Date08/08/2019
Device Model NumberRLT311415
Device Catalogue NumberRLT311415
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/23/2020
Initial Report FDA Received Date07/21/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age86 YR
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