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

Model Number	PLC121200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As gore was unable to determine which device(s) caused or contributed to the event if any; additional device(s) implanted related to this event include the following as referenced in 8021-1 : brand: gore® excluder® aaa endoprosthesis , product name: stent graft trunk ipsilateral leg c3 , catalog number: rlt261216 , lot/sn: (b)(4) ,and udi: (b)(4).(b)(4) - the medical device(s) remain implanted and were therefore not available for return and evaluation.
Event or Problem Description
On (b)(6) 2019 the patient underwent evar for an abdominal aortic aneurysm and was implanted with the following gore® excluder® evar endoprostheses: trunk ipsilateral leg component (rlt261216), contralateral leg component (plc121200), and aortic extender (pla280300).On (b)(6) 2022 cta was performed and identified type1b endoleak on the left limb.On (b)(6) imaging was conducted in order to confirm the suspected type1b endoleak.As reported it was causing the aneurysm sack to dilate.On (b)(6) 2022 the patient underwent a reintervention in which coverage down the left side was extended.The procedure was conducted without issue and it was confirmed that there were no remaining signs of endoleak.As reported, there was a large amount of calcium observed during the intervention but no thrombus was noted.It was also noted that the patient suffers from kawasaki disease (kd).It was requested, but information was not provided on whether or not the leak was on the contralateral or the ipsilateral side or how much the aneurysm had grown.
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.G3/g4 date received by manufacturer 25 april 2022 - manufacturing record review against specifications for the specified device and concomitant medical product was completed in full.H6: code 213, no device problem found ¿ a review of manufacturing records verified that the lots involved in this event met all pre-release specifications.H6 code 50, adverse event related to patient condition - related to ongoing treatment for kawasaki disease.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to endoleak and aneurysm enlargement.Further and according to the ifu regarding patient selection, treatment and follow-up, the safety and effectiveness of the gore® excluder® aaa endoprostheses have not been evaluated in the following patient populations: inflammatory aneurysms.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13795918
• Report Number: 2953161-2022-01127
• Device Sequence Number: 3892493
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: 05/10/2020
• Device Model Number: PLC121200
• Device Catalogue Number: PLC121200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2017
• 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; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 67 KG