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

Catalog Number RLT311413J

Device Problem Disconnection (1171)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/01/2021

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2017, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.On an unknown date in 2020, an aneurysm enlargement (amount unknown) was observed on the follow up ct imaging and a type ii endoleak was suspected.In (b)(6) 2021, the aneurysm enlargement more than 5mm compared with the follow up ct imaging in 2020 and type ii endoleak was observed, and a type iii endoleak(component disconnection) was also suspected.On (b)(6) 2022, a reintervention was performed.An additional stent graft was placed to treat the type iii endoleak.It was observed that the lumber artery that caused type ii endoleak arise from left internal iliac artery on the intra-operative angiography.Because the vessel was thin and tortuous, the physician decided to treat the type ii endoleak by surgical later.The procedure was completed, and the patient tolerated the procedure.

Manufacturer Narrative

As gore was unable to determine which abdominal component caused or contributed to the alleged type iii endoleak, an additional gore® excluder® component will be included on this report: catalog: plc181400j; lot: 15517482; udi: (b)(4).As the exact date the endoleak was identified is unknown, (b)(6) 2021 will serve as the date of event for this report.(b)(4).It should be noted the gore® excluder® aaa endoprosthesis instructions for use state ¿adverse events that may occur and/or require intervention include, but are not limited to, endoleak.¿ per ifu, users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13523753
• MDR Text Key: 289689204
• Report Number: 3007284313-2022-01771
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: RLT311413J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/14/2022
• Date Device Manufactured: 01/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male