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

Catalog Number	RLT281214
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2014, the patient was treated for an abdominal aortic aneurysm.The physician implanted two gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2023, imaging revealed a type ia and type ib endoleak, as well as a type ii endoleak.The fsa believes that the type ii endoleak caused neck dilatation, resulting in the two type i endoleaks.Reintervention is planned.Images are available.
Additional Manufacturer Narrative
The imaging evaluation performed by a clinical imaging specialist showed the following: ¿ one time-point available for evaluation: post-implantation cta dated (b)(6) 2023.¿ there is contrast outside the implanted device.¿ the length from the left renal artery to the proximal circumferential device appears to be ~13.5mm ¿ aortic diameter just distal to the left renal artery appears to be ~21mm.¿ aortic diameter within this 13.5mm portion, distal to the left renal, appears to be 30mm.¿ aortic diameter at the level of the proximal circumferential device appears to be ~31.3mm.¿ findings are consistent with a proximal type i endoleak.¿ there appears to be 2 different sets of lumbar arteries that communicate with contrast in the sac.Probable type ii endoleaks, however, cannot confirm ante grade or retrograde flow and/or without delayed contrast imaging.¿ there is lack of apposition of the distal limb in the rci.Contrast is visualized outside the implanted device limb.
Additional Manufacturer Narrative
H.6.Type of investigation - code b15 as a result of the completion of imaging evaluation.Additional review of returned images indicates that an additional unknown excluder device was implanted, and was the source of a type ib endoleak.
Additional Manufacturer Narrative
H.6.Type of investigation code b21 updated to code b14 and b21 with completion of phr review h.6.Investigation conclusions: code d16 updated to code d15.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, endoleaks.
Additional Manufacturer Narrative
This event also includes device (b)(6)/(b)(4).

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES, INC.; 3750 kiltie lane; flagstaff AZ 86005
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17769649
• Report Number: 3007284313-2023-02763
• Device Sequence Number: 7520149
• Product Code: MIH
• UDI-Device Identifier: 00733132622498
• UDI-Public: 00733132622498
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/29/2024

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: 06/30/2017
• Device Catalogue Number: RLT281214
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 08/23/2023; 08/23/2023; 08/23/2023; 08/23/2023; 08/23/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/04/2023; 10/17/2023; 01/05/2024; 01/25/2024; 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• 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: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male