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

Catalog Number CXT321414E

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Activation Problem (4042)

Patient Problem Aneurysm (1708)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

H6: code c20- a review of the manufacturing record for the device is going to be conducted.The investigation is in process.The device remains implanted and is not available for investigation.Images were sent to gore for analysis.Further information will be provided.Code f28 was used to cover that the physician is monitoring the patient.A re-intervention is planned on (b)(6) 2023.Code a26 was used to cover that according to the fsa personal point of view, the main body was not completely opened proximally.The physician did not notice this.The investigation is in process.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 Description

On (b)(6) 2020, the patient underwent endovascular procedure using a gore® excluder® conformable aaa endoprosthesis to treat an abdominal aortic aneurysm.The control ct on (b)(6) 2020 confirmed that there was no issue with a device or the patient.The follow up ct scan on (b)(6) 2023 showed the contrast in the aneurysm sac and confirmed the aneurysm enlargement from 45x59mm (pre-treatment) to 63x50mm.A cause of the aneurysm enlargement was a suspected endoleak.It is unknown if it was a proximal type i endoleak or a type ii endoleak.A re-intervention is planned on (b)(6) 2023 to confirm a proximal type i endoleak and/or a type ii endoleak from lumbar arteries.If a proximal type iendoleak is confirmed, a cxa360005e is planned to be implanted.The physician shared the images with the gore field sales associate (fsa) asking the fsa¿s opinion.According to the fsa personal point of view, the main body was not completely opened proximally.The physician did not notice this.

Manufacturer Narrative

B6: imaging evaluation was added.H6: code c19- a review of the manufacturing record for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for investigation.Please note that the imaging and engineering could not confirm that the device is not fully expanded.Additionally, a type i endoleak could not be confirmed.According to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to aneurysm enlargement and endoleak.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
• Type of Device: 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17656481
• MDR Text Key: 322361420
• Report Number: 3007284313-2023-02731
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Catalogue Number: CXT321414E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male