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

Model Number	RMT261418
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Aneurysm expansion (4597)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The patient referenced in this event file is enrolled in a post market prospective observational cohort registry designed to obtain data on device performance and clinical outcomes of patients treated with gore endovascular aortic products through the global registry for endovascular aortic treatment (great).Medidata rave® is the clinical study database (csd), capturing the data through the grt 10-11 module.The above information was obtained from the csd.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), 2013, a patient presenting with abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.On december 9, 2022, it was decided to treat an endoleak and aneurysm growth with coil embolization.The reintervention is planned for (b)(6), 2023.
Additional Manufacturer Narrative
Corrected manufacturing site.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The imaging evaluation performed by a clinical imaging specialist showed the following: one set of selective angiogram imaging submitted for evaluation dated on (b)(6) 2023.Cannot identify a type ii endoleak.Cannot determine aneurysm growth with angiogram imaging.Cannot identify coil embolization on images provided.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.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 endoleak.
Event or Problem Description
It was reported that on (b)(6) 2013, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2013, the maximum diameter of the aortic aneurysm was measured as 100 mm via ct imaging.On (b)(6) 2022, aneurysm growth was detected.No ct imaging was documented on this date.The growth amount is unknown.A type ii endoleak was reported by the physician.Ct imaging on (b)(6) 2022 showed a maximum diameter of the aortic aneurysm of 130 mm.On (b)(6) 2023, the aneurysm growth was treated with coil embolization.

• 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86004
• Manufacturer Contact: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16548043
• Report Number: 3007284313-2023-02388
• Device Sequence Number: 5946608
• Product Code: MIH
• UDI-Device Identifier: 00733132610655
• UDI-Public: 00733132610655
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2023

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: 04/30/2016
• Device Model Number: RMT261418
• Device Catalogue Number: RMT261418
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 09/14/2023; 09/29/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 09/14/2023; 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2013
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 76 KG