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

Model Number	PXC141400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications norvasc, aspirin, lipitor, lopressor.
Event or Problem Description
On (b)(6) 2017, the patient was implanted with gore¿ excluder¿ aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that computed tomography images dated (b)(6) 2021, the physician noted disease progression and growth (new aneurysm) of the left common iliac artery distal to the initial device placement without the presence of an endoleak.The flow lumen was stable.There was no aneurysm sac enlargement.On (b)(6) 2021, the physician decided to coil embolize the left internal iliac artery and extend the original endograft (pxc141400/15929867) into the left external iliac artery to achieve seal and treat the disease progression.The procedure went well, and the patient tolerated the procedure.
Additional Manufacturer Narrative
H6: added codes following completion of investigation.4112 - analysis of data provided by user/3rd party (images provided for evaluation) 213 - no device problem found added 4315 - cause not established.

• 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: 11766412
• Report Number: 2953161-2021-01060
• Device Sequence Number: 14575856
• Product Code: MIH
• UDI-Device Identifier: 00733132609963
• UDI-Public: 00733132609963
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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
• Report Date (Section B): 06/22/2021

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: 01/26/2020
• Device Model Number: PXC141400
• Device Catalogue Number: PXC141400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88