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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 PXT281412
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 03/30/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
Fsa brion crow received a text from a physician that a gore® excluder® aaa endoprosthesis implanted in 2008 had migrated.It was a proximal migration with a type 1 endoleak.The physician has not contacted the fsa about a reintervention.
 
Additional Manufacturer Narrative
Further review has determined that this event is not reportable, and the medwatch is retracted.
 
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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 Key11717842
Report Number2017233-2021-01890
Device Sequence Number3444648
Product Code MIH
UDI-Device Identifier00733132610297
UDI-Public00733132610297
Combination Product (Y/N)N
Initial Reporter StateFL
PMA/510(K) Number
P020004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/21/2021
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 Date06/30/2011
Device Model NumberPXT281412
Device Catalogue NumberPXT281412
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/30/2021
Supplement Date Received by Manufacturer03/30/2021
Initial Report FDA Received Date04/23/2021
Supplement Report FDA Received Date05/21/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age84 YR
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