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

Model Number	RLT281412
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Unspecified Infection (1930); Ruptured Aneurysm (4436)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6)2022, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2022, an indeterminate endoleak, suspected to be a type ii, was observed.A reintervention was performed whereby a terumo treo® aortic extender cuff was placed across the patient's renal arteries.Stent/laser fenestration of the renal arteries was performed, and medtronic endoanchors were placed at the overlap.There were no further reported issues.The patient reportedly recovered.
Additional Manufacturer Narrative
A.4.Patient weight: this information has been requested but has not yet been provided to gore.B.7.Other relevant history, including preexisting medical conditions: this information has been requested but has not yet been provided to gore.D.10.Concomitant medical products and therapy dates: this information has been requested but has not yet been provided to gore.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) 2022, along with the reported indeterminate endoleak, the patient reportedly presented with an acute aneurysm rupture.The cause of rupture is unknown, but device migration was suspected.On an unknown date, the patient reportedly presented with infection of the aneurysm.The infection was suspected to be related to the aneurysm rupture.Exploratory laparotomy was performed, thrombus was removed from around the implanted gore® excluder® endograft, the aneurysm sac was packed, and the patient was closed without device explant.The physician also reported that the type ii endoleak was coil embolized.There were no further reported issues.The patient reportedly recovered.
Additional Manufacturer Narrative
B.4.Event description: additional information added.H.6.Health effect - clinical code: code e1906 added.H.6.Medical device problem code: code a010402 added.H.6.Type of investigation: code b15 added.H.6.Type of investigation: code b15 - images were provided, and an imaging evaluation was performed.H.6.Investigation findings for imaging evaluation: code c19 - the imaging evaluation found the following: on the ct images dated december 5, 2022, there appears to be poor proximal wall apposition.There is no contrast that communicates with the aneurysmal sac.There are patent lumbar arteries and a patent ima that communicate with contrast pooling in the aneurysmal sac.This is consistent with a type ii endoleak.There is an unknown density surrounding the aorta.H.6.Investigation conclusion: code d12 added.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoleak, component migration, aneurysm enlargement, aneurysm rupture, and infection (e.G., aneurysm, device or access sites).H.6.Health effect - clinical code: code e0501 updated to code e050101.H.6.Component code: code g07001 updated to code g04122.H.6.Investigation findings for communication/interviews: code c21 updated to code c19.H.6.Investigation conclusion: code d16 updated to code d15.
Additional Manufacturer Narrative
H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation findings for communication/interviews: code c21 remains unchanged.H.6.Investigation conclusions: code d16 remains unchanged h.6.Investigation findings for analysis of production records: code c21 updated to code c19.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16792291
• Report Number: 3007284313-2023-02457
• Device Sequence Number: 5692230
• Product Code: MIH
• UDI-Device Identifier: 00733132622528
• UDI-Public: 00733132622528
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2023

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: 05/08/2025
• Device Model Number: RLT281412
• Device Catalogue Number: RLT281412
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 06/06/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/05/2023; 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male