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

Catalog Number RMT281216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ruptured Aneurysm (4436)

Event Date 12/23/2020

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2015, a patient presenting with abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2020, the patient presented with hemoperitoneum due to rupture of the anastomosis between left iliac branch of previous evar and surgical iliac graft.The patient was treated with an additional device that day.

Manufacturer Narrative

D10: gore® excluder® aaa endoprosthesis pxc141000 excluder 14.5mmx10cm (b)(6).Gore® excluder® aaa endoprosthesis pxa280300 excluder 28.5mmx3.3cm (b)(6).Gore® excluder® aaa endoprosthesis pxl161207 excluder 16mmx12mmx7cm (b)(6).H3: device remains implanted.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.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met pre-release specifications.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 aneurysm rupture.

Event Description

It was reported that on (b)(6) 2015, a patient presenting with abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis.On (b)(6) 2020, the patient presented with rupture of the abdominal aortic aneurysm.The patient was treated with an aortobiiliac bypass.On (b)(6) 2020, the patient presented with hemoperitoneum due to rupture of the anastomosis between left iliac branch of previous endovascular repair and surgical iliac graft.The patient was treated with an additional device that day.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: 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: 18969248
• MDR Text Key: 338497027
• Report Number: 3007284313-2024-03132
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132610686
• UDI-Public: 00733132610686
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

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
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: RMT281216
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male