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

Model Number	CXT281212
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, the patient was admitted for endovascular aortic repair of an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis.Reportedly, during deployment the device was reconstrained four separate times.As reported, each time the device was reconstrained it reopened with one side slightly lower (1960-e:-other/unknown).As reported, following the fourth attempt to reposition and reopen the endoprosthesis the physician decided to proceed by leaving the endoprosthesis where it was, with one side of the leading edge slightly lower, and added a gore® excluder® conformable aaa endoprosthesis aortic extender component.The patient was treated effectively.
Additional Manufacturer Narrative
Additional event and patient related information has been requested and will be added to the investigation and conclusions once provided.(b)(4).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
The following patient information was requested, but has not been provided: name, date of birth, gender, weight, medications, comorbidities.H6.Code c19, no device problem found: a review of manufacturing records verified that the lot involved in this event met all pre-release specifications.H6.Code d15, cause not established: the device evaluation performed by engineering showed the following: the cxt281212 excluder® conformable aaa endoprosthesis lot/serial 23410750 was not returned for analysis, nor were any images provided for an engineering evaluation.Because no device or device images were available by which to perform an engineering evaluation, no manufacturing deficiencies could be identified and the observations in the event description could not be confirmed.As a result, a capa request is not required per md145952 (revision 24), engineering evaluation task procedure.This type of event will continue to be monitored through md24024.Added component code g04122, stent.G3/g4 date received by manufacturer 21-oct-2022 as production record review and engineering analysis were completed in full on this date.H6.Code c21, results pending completion of investigation was replaced with findings.H6.Code d16, conclusion not yet available replaced with conclusions.
Additional Manufacturer Narrative
Corrected the component/annex g code to device deployer from stent.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15396871
• Report Number: 3007284313-2022-02106
• Device Sequence Number: 14704107
• Product Code: MIH
• UDI-Device Identifier: 00733132651047
• UDI-Public: 00733132651047
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: CXT281212
• Device Catalogue Number: CXT281212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 10/21/2022; 10/21/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/24/2022; 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown