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

Catalog Number CXT231212E

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190); Activation Failure (3270); Activation Problem (4042)

Patient Problem Aneurysm (1708)

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

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.Additional information was requested.Further information will be provided.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), 2023, the patient underwent endovascular procedure to treat an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis and gore® excluder® aaa endoprostheses.It was reported that the first sleeve during the deployment of the proximal portion of the graft didn¿t open fully.According to the reported information, the device did not perform as expected.There was a proximal type i endoleak on completion that was not expected.There was no enough space to add an aortic extender.After using the endoanchors on one side, the device had slipped down enough to add the aortic extender.The endoleak was resolved.The treatment was successful.The patient tolerated the procedure.

Manufacturer Narrative

B5: the event description was updated due to the additional information received.B6: was updated due to the additional information received.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.Images were requested.Further information will be provided.

Event Description

On (b)(6) 2023, the patient underwent endovascular procedure to treat an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis and gore® excluder® aaa endoprostheses.It was reported that the first sleeve during the deployment of the proximal portion of the graft didn¿t open fully.Reportedly, the deployment issue was due to the secondary sleeve was too high and was not allowing the full diameter of the graft.The physician used a coda balloon to fully extend the device.There was a proximal type i endoleak on completion that was not expected.Reportedly, once fully deployed, there was not enough space distal to renals and proximal to stent to add an aortic cuff.The surgical team considered a palmaz stent.Imaging confirmed that the aortic length was inside ifu.The patient had the angulation of the aortic short neck to renal arteries.The physician used the balloon to resolve the endoleak, however, it was not fixed.The surgical team considered to use the endoanchors.After the endoanchors were placed in the graft it shifted about 5mm and it was enough to add the aortic extender.The endoleak was resolved.No further adverse events were noticed or reported.No issues were noted with other devices used during the procedure.The physician confirmed that there was no vessels coverage noticed.According to the physician, in spite of the device did not perform as expected, the treatment was successful.The patient tolerated the procedure.

Manufacturer Narrative

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.Based on the imaging evaluation, it is unable to confirm the leading end of endoprosthesis unable to be fully reopened.Unable to confirm device moves distally of intended position after deployment.Based on the imaging evaluation, the aortic neck angle measures ~71 degrees.According to the ifu, the gore® excluder® conformable aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as described below: proximal aortic neck angulation = 60°.The safety and effectiveness of the gore® excluder® conformable aaa endoprosthesis have not been evaluated in the following patient populations: patients with less than 15 mm in length or > 60° angulation of the proximal aortic neck.Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (> 60°).The ifu states: adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: incomplete component deployment, component migration and endoleak.

• 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: 16633101
• MDR Text Key: 312463120
• Report Number: 3007284313-2023-02409
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CXT231212E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/20/2023; 05/16/2023
• Supplement Dates FDA Received: 04/24/2023; 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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 Sex: Female