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

Model Number	RLT351416
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: aspirin, lopressor, lipitor, catapres, nitrostat.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) 2020, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that the trunk-ipsilateral leg component was placed low initially (distance from the patient's renal arteries is unknown).On (b)(6) 2022, it was reported that the trunk-ipsilateral leg component had migrated distally.It was suspected that the migration was related to the initial low placement of the device, as well as a lack of full circumferential device apposition as the initial seal was reportedly opposed to clot.It was noted that the aneurysm was thrombosed and no endoleak was reported.It was reported that a reintervention was performed whereby two gore® excluder® conformable aaa aortic extender components were implanted proximally to treat the distal migration.The treatment was reportedly successful and there were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
Investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, component migration.Furthermore, the ifu states that key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation, short proximal aortic neck, and significant thrombus and/or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.The us clinical studies quantify significant thrombus as thrombus = 2 mm in thickness and/or = 25% of the vessel circumference in the intended seal zone of the aortic neck.Irregular calcium and/or plaque may compromise the fixation and sealing of the implantation sites.H.6.Investigation findings: code c21 updated to code c19.Investigation conclusions: code d16 updated to code d15.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15890545
• Report Number: 3007284313-2022-02244
• Device Sequence Number: 17840967
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: 00733132618484
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: 04/09/2023
• Device Model Number: RLT351416
• Device Catalogue Number: RLT351416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/11 FOR LIST OF MEDICATIONS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 62 KG