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

Model Number	RLT351418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The field sales associate (fsa) reported: on (b)(6) 2015, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.Reportedly during this procedure, the physician tapered down the implanted grafts 32mm from the renal arteries to 24mm distally.The physician had implanted a cook cuff stent proximal of the trunk-ipsilateral leg endoprosthesis.The patient tolerated the procedure.It was reported that on (b)(6) 2022, the patient was admitted emergently.A type iii endoleak was revealed (separation between the cook stent and the trunk-ipsilateral leg endoprosthesis) and aneurysm sac enlargement (amount is unknown).The patient underwent endovascular treatment to reline 8cm of length, from the lowest renal artery to the flow divider of the implanted trunk-ipsilateral leg endoprosthesis.The patient tolerated the reintervention.

• 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
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13765641
• Report Number: 2017233-2022-02804
• Device Sequence Number: 3812629
• Product Code: MIH
• UDI-Device Identifier: 00733132618491
• UDI-Public: 00733132618491
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

1 Device 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: 01/31/2017
• Device Model Number: RLT351418
• Device Catalogue Number: RLT351418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial