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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 PXL161207
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Ruptured Aneurysm (4436)
Date of Event 10/28/2018
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2015.This patient underwent endovascular treatment of an abdominal aortic aneurysm using gore excluder aaa endoprosthesis.On (b)(6) 2018.A rupture of the right internal iliac artery aneurysm was reported.The patient was converted to open repair to treat the rupture.
 
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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 Key11454877
Report Number2953161-2021-01051
Device Sequence Number19612414
Product Code MIH
UDI-Device Identifier00733132610075
UDI-Public00733132610075
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P020004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/10/2021
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 Date08/31/2016
Device Model NumberPXL161207
Device Catalogue NumberPXL161207
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/09/2021
Initial Report FDA Received Date03/10/2021
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;
Patient Age68 YR
Patient Weight80
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