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

Model Number CXT231412

Device Problem No Apparent Adverse Event (3189)

Event Date 06/06/2023

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2023, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis.Reportedly, during the initial procedure, due to accordion phenomenon of the proximal neck , the landing length became slightly short, but no proximal type i endoleak was observed on the intraoperative digital subtraction angiography(dsa.) the procedure was completed without any issue.On an unknown date, a proximal type i endoleak was suspected on the follow-up computed tomography imaging.On (b)(6) 2023, a intervention was performed, an additional stent graft was placed proximally.No obvious proximal type i endoleak was reportedly observed on the intraoperative dsa.The patient tolerated the procedure.

Manufacturer Narrative

H.6.Medical device problem code a25: a reintervention was performed based on a suspected endoleak, however there was no sign of an endoleak during the reintervention.H.6.Type of investigation code b20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c21: conclusions pending completion of product history review.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.

Manufacturer Narrative

H.6.Investigation findings code c19: a review of the manufacturing records for this device verified the lot met all pre-release specifications.H.6.Investigation findings code c21 replaced with c19.H.6.Investigation conclusions code d16 replaced with d15.

Manufacturer Narrative

H.6.Investigation conclusions code d12: 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: endoleak.G.2.Report source - corrected foreign h.6.Investigation conclusions added code d12.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17221605
• MDR Text Key: 318072969
• Report Number: 3007284313-2023-02583
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651016
• UDI-Public: 00733132651016
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CXT231412
• Device Catalogue Number: CXT231412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female