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

Catalog Number	CXA280005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Product evaluation summary: the image received cannot be used to perform a full imaging evaluation because it does not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the image provided for review.Gore cannot guarantee all key findings have been captured or that the findings are accurate.The imaging evaluation performed by a clinical imaging specialist showed the following: ¿ one radiographic jpeg image provided for evaluation.¿ no name, date, or demographics on the image.¿ cannot manipulate the image in any way.(window level, rotating, etc.) ¿ there appears to be some distortion in the wire pattern at the proximal end of the most proximal device which is an aortic extender identified by the 3 long radiopaque markers present proximally.A short radiopaque marker is also present near the proximal markers of the aortic extender.This finding could represent a turned up distal end of the device.¿ the image provided also shows there are 3 additional long radiopaque markers present more distally, thereby confirming the presence of a 2nd aortic extender.¿ other device markers confirm the presence of a gore® excluder® conformable aaa endoprosthesis.Amount of device overlap and the presence of an endoleak cannot be confirmed or ruled out with the non-contrast angiogram image provided for evaluation.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 or Problem Description
On (b)(6) 2024, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis.After the aortic extender component was deployed, it was observed that the distal side of the device got turned up.The wrinkles were improved with touch-up ballooning, but the turned up was not improved.A cone beam computed tomography(cbct) was performed to be sure, and although wrinkles were observed in the turned-up area, the physician determined that it will be no problem, and the procedure was completed.The patient tolerated the procedure.The physician reported that the device was deployed too slowly, which might have caused this event.

• 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: hiroko sakamiya ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20900147
• Report Number: 3007284313-2024-03647
• Device Sequence Number: 9032906
• Product Code: MIH
• UDI-Device Identifier: 00733132650958
• UDI-Public: 00733132650958
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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 Catalogue Number: CXA280005
• 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: 11/20/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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
• Patient Age: 82 YR
• Patient Sex: Male