MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE EXCLUDER AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	PXC141000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications: triamcinolone acetonide, eliquis, fish oil, carvedilol, and simvastatin according to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), potential device or procedure related adverse events that may occur and/or require intervention include, but are not limited to: endoleak.
Event or Problem Description
On (b)(6) 2017, this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses, and treatment of a right iliac aneurysm treated with gore® excluder® iliac branch endoprostheses.It was reported that an endoleak (unknown type) in the right external iliac artery was revealed (modality and date is unknown).The aneurysm in the right external iliac artery had enlarged (amount of enlargement is unknown).The physician reintervened on (b)(6) 2020, and relined and extended the implanted contralateral leg endoprosthesis (pxc141000/14826821) with a contralateral leg endoprosthesis proximally and distally.The physician also coil embolized the right hypogastric artery.The endoleak was resolved.The patient tolerated the reintervention procedure.
Additional Manufacturer Narrative
Addition h6: code 213-a review of the manufacturing records for the device verified that the lot met all pre-release specifications.
Additional Manufacturer Narrative
Addition g5.

• 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 Key: 10681079
• Report Number: 2953161-2020-01025
• Device Sequence Number: 19589529
• Product Code: MIH
• UDI-Device Identifier: 00733132609949
• UDI-Public: 00733132609949
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2021

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: No Information
• Device Expiration Date: 03/01/2019
• Device Model Number: PXC141000
• Device Catalogue Number: PXC141000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 10/08/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/29/2020; 01/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 98