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

Catalog Number	RLT261416
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.The trunk ipsilateral leg was implanted using a ballerina technique.Post operative imaging showed limb compression in the contralateral leg and a possible wire fracture in the trunk ipsilateral leg.No endoleaks were observed and the devices were patent.The device appears to be compressed but hemodynamics appear to be normal and the patient is not presenting with any symptoms.No reintervention is planned.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lots met pre-release specifications.The imaging evaluation performed by a clinical imaging specialist showed the following: five time-points available for evaluation: pre-implantation cta dated (b)(6) 2023, intra-operative angiogram images dated (b)(6) 2023, post-implantation cta¿s dated (b)(6) 2023, (b)(6)2023, and (b)(6) 2023.The intra-operative angiogram imaging is black.Unable to window level images to see anatomy or devices.Post ¿ implantation images show the ballerina technique was utilized for the implantation of the excluder device and limbs.The ipsilateral limb on the patient¿s left side proximally, crosses under the contralateral leg and is deployed in the rci.This technique appears to compress a small area of the ipsilateral limb.¿ diameters change within the ipsilateral limb on each time-point: (b)(6) 2023 ¿ 4.84mm, o (b)(6) 2023 ¿ 4.61mm, o (b)(6) 2023 ¿ 3.86mm.Flow is visualized throughout both limbs on all time-points.¿ unable to confirm wire fracture in the ipsilateral limb.D10: additional devices gore® dryseal flex introducer sheath dsf1833 27154869 dsf1233 27360696 gore® excluder® aaa endoprosthesis plc161200 25708266 plc141000 25798211 plc161000 27112770 gore® molding & occlusion balloon mob37 27284800 h3: device remains implanted 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
It was reported that on (b)(6) 2023, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.The trunk ipsilateral leg was implanted using a ballerina technique.Post operative imaging showed compression of the trunk ipsilateral leg where it passes under the contralateral leg in a ballerina technique.A possible wire fracture in the trunk ipsilateral leg was also reported.No endoleaks were observed and the devices were patent.The device appears to be compressed but hemodynamics appear to be normal and the patient is not presenting with any symptoms.No reintervention is planned.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lots met pre-release specifications.The imaging evaluation performed by a clinical imaging specialist showed the following: five time-points available for evaluation: pre-implantation cta dated (b)(6) 2023, intra-operative angiogram images dated (b)(6) 2023, post-implantation cta¿s dated (b)(6) 2023.The intra-operative angiogram imaging is black.Unable to window level images to see anatomy or devices.Post ¿ implantation images show the ballerina technique was utilized for the implantation of the gore® excluder® aaa endoprosthesis device and limbs.The ipsilateral limb on the patient¿s left side proximally, crosses under the contralateral leg and is deployed in the rci.This technique appears to compress a small area of the ipsilateral limb.Diameters change within the ipsilateral limb on each time-point: (b)(6) 2023 ¿ 4.84mm, (b)(6) 2023 ¿ 4.61mm, (b)(6) 2023 ¿ 3.86mm.Flow is visualized throughout both limbs on all time-points.Unable to confirm wire fracture in the ipsilateral limb.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18272785
• Report Number: 3007284313-2023-02920
• Device Sequence Number: 4006713
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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 Expiration Date: 12/11/2025
• Device Catalogue Number: RLT261416
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown