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

Model Number	RLT311417
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: cerebrovascular accident, aaa ascending aorta, peripheral vascular disease, gastroesophageal reflux disease, chronic constipation, neck pain, ankylosing spondylitis, osteopenia, vertigo, dyspnea, impaired glucose tolerance, vitamin d deficiency, hyperlipidemia, hyponatremia, impotence, hypertension, coronary arteriosclerosis, aortic valve regurgitation, afib premature atrial contraction left ventricular cardiac dysfunction patient medications include but are not limited to: brio ellipta, coq, eliqis, fish oil, hydrocortisone, linzess, lisinoprol, magnesium, metoprolol, milk of magnesia, multivitamin, nortiptyline, omeprazole, ophenadrine citrate, oxygen, restasis, (b)(4).W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® conformable aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2022, the physician reported that the patient had a suspected proximal type i endoleak or a type ii endoleak and planned to reintervene on (b)(6) 2022.On (b)(6) 2022, the patient underwent reintervention and a conformable aortic extender component was placed proximally to extend coverage.The patient tolerated the procedure.The physician reports that while no endoleak was visualized, some aneurysm enlargement was noted.The patient was reported to have a short angulated neck, exact dimensions were not provided but believed to be within treatment range recommended.The amount of enlargement was not known.
Additional Manufacturer Narrative
B4: device implanted on (b)(6), 2021 was a gore® excluder® aaa endoprostheses featuring c3® delivery system.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14718333
• Report Number: 3007284313-2022-01973
• Device Sequence Number: 2175509
• Product Code: MIH
• UDI-Device Identifier: 00733132619092
• UDI-Public: 00733132619092
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2024
• Device Model Number: RLT311417
• Device Catalogue Number: RLT311417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 83 KG