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

Catalog Number	RLT351414
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B.3.Date of event: as the date of identification of device migration is unknown, the date of event has been estimated as the date of reintervention - (b)(6) 2023.B.7.Other relevant history, including preexisting medical conditions: this information has been requested, but has not yet been made available to gore.D.10.Concomitant medical products and therapy dates: this information has been requested, but has not yet been made available to gore.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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) 2018, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that, on an unknown date, it was observed that the patient's aortic neck had grown and the trunk-ipsilateral leg component had migrated distally (distance unknown).On (b)(6), a reintervention was performed.A gore® tag® conformable thoracic stent graft with active control system, a gore® excluder® aaa aortic extender component, and a gore® excluder® conformable aaa aortic extender component were used to achieve proximal seal.The patient tolerated the reintervention.
Additional Manufacturer Narrative
B.5.Event description: additional information added.H.6.Investigation conclusions: code d12 added.According to the gore® excluder® aaa endoprosthesis instructions for use, 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, aneurysm enlargement and component migration.H.6.Investigation findings for communication/interviews: code c21 updated to code c19 h.6.Investigation conclusions: code (b)(6) updated to code (b)(6).
Event or Problem Description
It was reported that, on an unknown date, it was observed that the patient's aortic neck had dilated and the trunk-ipsilateral leg component had migrated approximately 3cm distally.Aneurysm enlargement of approximately 2cm was also observed.
Additional Manufacturer Narrative
H.6.Type of investigation: code b15 added.H.6.Type of investigation: code b15 - images were provided, and an imaging evaluation was performed.H.6.Investigation findings: code c19 added.H.6.Investigation findings: code c19 - four angiogram still jpeg images were provided for evaluation, and the imaging evaluation found the following: no name, date, or demographics were present on the images.Unable to provide aortic diameters with angiogram images.Jpeg image #2 shows that the gore® excluder® aaa endoprosthesis and gore® tag® conformable thoracic stent graft with active control system (ctag a/c) do not have proximal circumferential device apposition.The proximal end of the devices are distal to the distal border of the renal arteries.Jpeg image #3 shows the presence of a balloon catheter near the sheath extending from the right common iliac artery.Jpeg image #1 appears to show two deployed aortic extenders (per six additional long radiopaque markers present) located proximal to the previously deployed ctag a/c device.On jpeg image #4 the proximal end of the most proximal aortic extender is visualized at the level of the renal arteries, with the projection provided.There is flow in the renal arteries.The proximal wire patterns appear to be different compared to jpeg image #1.Cannot window level or manipulate the image in any way.Radiopaque markers are not visualized as prominently in jpeg image #4 as they were in jpeg image #1.Cannot confirm if there is an additional device implanted.H.6.Investigation conclusions: codes d1001 and d12 remain unchanged.

• 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: 17840445
• Report Number: 3007284313-2023-02778
• Device Sequence Number: 6830828
• Product Code: MIH
• UDI-Device Identifier: 00733132618477
• UDI-Public: 00733132618477
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2024

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: 01/07/2021
• Device Catalogue Number: RLT351414
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/05/2023; 10/05/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/03/2023; 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG