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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 RLT351418
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Aneurysm (1708)
Date of Event 11/09/2020
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2020 this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses featuring c3® deployment system.On (b)(6) 2020, gore became aware that the device had migrated distally.On (b)(6) 2020, a reintervention occurred to treat the migration.Details concerning the treatment has not been reported to gore.
 
Additional Manufacturer Narrative
Corrected data- g1: manufacturing site and address.
 
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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 Key11003453
Report Number3007284313-2020-01192
Device Sequence Number3562459
Product Code MIH
UDI-Device Identifier00733132618491
UDI-Public00733132618491
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P020004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/08/2021
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 Date04/06/2023
Device Model NumberRLT351418
Device Catalogue NumberRLT351418
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/16/2020
Supplement Date Received by Manufacturer11/16/2020
Initial Report FDA Received Date12/14/2020
Supplement Report FDA Received Date06/08/2021
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 Required Intervention;
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