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

Model Number	CXA360005
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2023, the patient underwent an endovascular procedure in zone 9-infrarenal to treat an aortic aneurysm utilizing gore® excluder® conformable aaa endoprosthesis (aortic extender, trunk ipsilateral leg), and gore® excluder® aaa endoprosthesis (contralateral leg).Reportedly, the aortic extender had to be opened up in the case as the main body's (trunk ipsilateral leg) constraining loop malfunctioned and the main body trunk device had to be pulled down a little.The reason being that one of the stents on the proximal top side of the trunk was flipped or inverted, and not upright.Physician tried pulling it down a bit to get the stent to unflip and straighten but it would not open up as the constraining mechanism broke at which point they put a mob balloon in and inflated it that led to the trunk ipsi being opened back up, however, the device was bit below the renals from the intended landing zone as they had pulled it down and an aortic extender was put in to extend proximally to renals.However, the aortic extender while it landed perfectly at the intended landing zone below the renals, it slid down 15mm into the main body of trunk ipsi leg and the medical team did not want to put in another aortic extender.All devices were implanted successfully, there were no endoleaks.The patient tolerated the procedure.
Additional Manufacturer Narrative
According to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, endoprosthesis or delivery system: component migration.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: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.According to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, endoprosthesis or delivery system: : component migration.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17286911
• Report Number: 3007284313-2023-02609
• Device Sequence Number: 3011247
• Product Code: MIH
• UDI-Device Identifier: 00733132650972
• UDI-Public: 00733132650972
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 11/20/2025
• Device Model Number: CXA360005
• Device Catalogue Number: CXA360005
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female