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

Model Number	PXT231414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxc121400/7039722 udi (b)(4), and pxl161207/7121958 udi (b)(4).
Event or Problem Description
The following was reported to gore: on (b)(6) 2009, the patient underwent endovascular treatment of an abdominal aortic aneurysm (maximum diameter of the aneurysm was 47mm) using gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On an unknown date in 2019, the aneurysm enlargement was observed (amount unknown).The patient presented with shock due to the allergic reaction to contrast dye.The contrast dye could not be used for this patient, so the physician decided to perform a follow-up exam using plain computed tomography (ct).On an unknown date in 2020, the follow-up exam identified the maximum diameter of the aneurysm was 79mm.The root cause of the aneurysm enlargement was unknown because the angiography imaging was not able to be taken.The physician planned to do open surgery to treat the aneurysm enlargement, because this patient cannot take an endovascular treatment due to allergy of contrast dye.On (b)(6) 2020, the gore® excluder® aaa endoprostheses were explanted and the abdominal aorta was replaced as y graft.During the procedure, a proximal type i endoleak was slightly confirmed.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition h6: code 213-the review of the manufacturing paperwork verified that these lot/serial numbers met all pre-release specifications.Addition h6: code 22-the gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement, surgical conversion and endoleak.
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: 10291687
• Report Number: 2017233-2020-01034
• Device Sequence Number: 3294173
• Product Code: MIH
• UDI-Device Identifier: 00733132610143
• UDI-Public: 00733132610143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2021

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 Date: 02/29/2012
• Device Model Number: PXT231414
• Device Catalogue Number: PXT231414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 06/22/2020; 06/22/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/11/2020; 01/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR