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

Catalog Number	PXA260300
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6: code b20: device remains implanted and therefore not available for direct analysis.H.6.Code d12: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: aneurysm enlargement.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
The following information was reported to gore: on (b)(6) 2023, this patient underwent an endovascular treatment for abdominal aortic aneurysm and common iliac artery aneurysms using gore® excluder® aaa endoprostheses.All the planned devices were implanted successfully.Considering the diameter of common iliac arteries (right 16 ¿ 22 mm, left 16 - 22 mm), aortic extender components (right pxa280300, left pxa260300) were implanted in the distal end of bilateral sides.The patient tolerated the procedure.On (b)(6) 2023, a reintervention was performed as left common iliac aneurysm enlargement was found.Gore® excluder® iliac branch endoprosthesis (ibe) was planned to be placed in the left iliac artery.Prior to starting this reintervention, the fsa noticed evidence from the ct images that another reintervention had been performed on the right distal side as well.It appeared that an additional stent graft had been placed in the right side too after the initial procedure (timing and reason unknown).During the reintervention on (b)(6) 2023, the iliac branch component (ibc) was successfully deployed; however, delivery of the internal iliac component (iic) to the internal iliac artery (iia) was difficult.The reason was that the guidewire was not properly cannulated to the iia.While manipulating the iic delivery catheter, it was broken and the leading end was detached from the catheter.When the physician pulled the catheter to remove it, the iic was unintentionally deployed other than the target position (it was deployed inside the left leg part of the previously implanted excluder).The detached olive was retrieved by a snare catheter; placement of the iic was abandoned and the left iia was coil embolized.An additional contralateral leg was placed to bridge the iic which was unintentionally implanted and the ibc leg.No endoleak was found.The patient tolerated the procedure.The iic delivery catheter will be returned to gore for further investigation.The reporting physician commented as follows: the delivery catheter was broken possibly because it was advanced without noticing that the guidewire was passing outside the ibc.

• Brand Name: GORE® EXCLUDER®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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: kathryn irwin ; 1505 n. fourth street; flagstaff ; 9285263030
• MDR Report Key: 18352521
• Report Number: 2953161-2023-01195
• Device Sequence Number: 12865717
• Product Code: MIH
• UDI-Device Identifier: 00733132609888
• UDI-Public: 00733132609888
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 12/18/2023

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: 04/30/2014
• Device Catalogue Number: PXA260300
• 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: 11/21/2023
• Initial Report FDA Received Date: 12/18/2023
• Date Device Manufactured: 05/19/2011
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male