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

Model Number	RLT281416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, 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 (date and modality is unknown), revealed a proximal type i endoleak.There was aneurysm sac enlargement (amount is unknown).On (b)(6) 2021 there was a reintervention.The physician implanted a gore® excluder® aaa endoprosthesis aortic extender and a palmaz stent.The endoleak was resolved.The patient tolerated the reintervention procedure.
Additional Manufacturer Narrative
Addition 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.
Additional Manufacturer Narrative
Revised b1.

• 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: 11935354
• Report Number: 3007284313-2021-01446
• Device Sequence Number: 4345217
• Product Code: MIH
• UDI-Device Identifier: 00733132622542
• UDI-Public: 00733132622542
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2021

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: 03/13/2022
• Device Model Number: RLT281416
• Device Catalogue Number: RLT281416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021; 10/19/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 08/10/2021; 10/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR