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

Model Number	RMT231216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The field sales associate reported the following: on (b)(6) 2014, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient tolerated the procedure.It was reported that images (modality and date is unknown), revealed a possible type iii endoleak (tear in material) with aneurysm sac enlargement (amount of enlargement is unknown).On (b)(6) , 2022, the physician reintervened and implanted an aortic extender endoprosthesis and relined both limbs with contralateral leg endoprostheses.During the reintervention, no type iii endoleak was found, it is unknown what type of endoleak was present.The patient tolerated the procedure.
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxc121200/ 12396311 udi (b)(4) and pxc121400/ 11538497 udi (b)(4).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 endoleak and aneurysm enlargement.

• 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: 13773318
• Report Number: 2017233-2022-02806
• Device Sequence Number: 14700786
• Product Code: MIH
• UDI-Device Identifier: 00733132610525
• UDI-Public: 00733132610525
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: RMT231216
• Device Catalogue Number: RMT231216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2022
• Supplement Date Received by Manufacturer: 02/19/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 66 KG