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

Model Number	RMT231214
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582); Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2011, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2011, maximum aortic aneurysm/lesion measured 47 mm.On (b)(6) 2022, maximum aortic aneurysm/lesion measured 51 mm.All measurements were made with cta.On (b)(6) 2022, the patient was treated with an additional contralateral leg endoprosthesis (plc161200).The reason for the reintervention was unknown.
Additional Manufacturer Narrative
H6 code b13: additional information on the event and dicom image series were requested by the study coordinator.Images were released and forwarded to gore for analysis.The evaluation has not yet been completed.H3: other code & h6 code b20: device still remains implanted.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.
Additional Manufacturer Narrative
H6-b14 and c19: a review of the manufacturing records indicated the lot met all pre-release specifications.
Additional Manufacturer Narrative
Clinical images were provided for investigation.The imaging evaluation performed by a clinical imaging specialist showed the following: three jpeg images provided for evaluation.No names, dates, or demographics on images provided.Cannot provide aneurysm size information with angiogram imaging.Small distal portion of a contralateral limb is visualized, in the proximal rci, on the first jpeg image.Axial image (jpeg) shows lack of apposition at the distal contralateral limb in the rci.The post-op jpeg image shows an additional contralateral leg extending into the rci.There is flow throughout the implanted devices.No endoleaks can be identified with the imaging provided.A review of the manufacturing records indicated the lot met all pre-release specifications.This complaint was initiated based on information received from a study alert.Clinical images were shared with gore for evaluation.Based on the available images neither reported aneurysm growth nor suspected type 1b endoleak could be independently confirmed.The available information reported does not reasonably suggest a potential malfunction has occurred.Reported aneurysm growth and endoleaks represent known complications or adverse events that can occur when using stent-graft endovascular devices and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen, patient-related risk factors and disease progression.No allegation of device malfunction was indicated with respect to device performance.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to endoleak and aneurysm enlargement.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.
Event or Problem Description
It was reported that on (b)(6) 2011, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2011, the maximum diameter of the aortic aneurysm measured 47 mm via computed tomography angiography (cta) imaging.On (b)(6) 2016, the maximum diameter of the aortic aneurysm measured 44 mm via cta imaging.On (b)(6) 2016, the maximum diameter of the aortic aneurysm measured 59 mm via cta imaging.On (b)(6) 2022, the patient was treated with the implantation of an additional contralateral leg endoprosthesis in the right common iliac artery in response to a risk of a type ib endoleak.The physician believes that a short landing zone less than 1 cm contributed to the endoleak.The patient tolerated the procedure.

• 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: kerstin haberlaender ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17285642
• Report Number: 3007284313-2023-02606
• Device Sequence Number: 16899646
• Product Code: MIH
• UDI-Device Identifier: 00733132610518
• UDI-Public: 00733132610518
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2023

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: 12/31/2013
• Device Model Number: RMT231214
• Device Catalogue Number: RMT231214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 07/11/2023; 12/01/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/11/2023; 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2011
• 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; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 93 KG