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

Model Number RLT311413

Device Problem Material Invagination (1336)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/26/2022

Event Type  Injury  

Manufacturer Narrative

Medications: finasteride, acetaminophen, aspirin, atorvastatin, clopidogrel, folic acid, metoprolol, nitroglycerin, and tamsulosin.Comorbidities/conditions: history of cerebral vascular accident (cva), hypertension (htn), hyperlipidemia (hld), and peripheral vascular disease (pvd).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.

Event Description

On (b)(6) 2019 the patient was admitted and endovascular repair of an abdominal aortic aneurysm was conducted.Gore® excluder® iliac branch endoprostheses (ibes) were extended into the internal iliac artery on the right side and the gore® excluder® aaa trunk ipsilateral endoprosthesis (rlt 311412, sn: (b)(4)) was bridged on the right side of the ibe with the with a plc271000 and extended into the left common iliac artery with another plc271000.On (b)(6) 2022 the patient presented with flank pain.A ct was performed and showed proximal left posterolateral stent collapse in the aortic portion of the previously implanted gore® excluder® aaa trunk ipsilateral endoprosthesis (rlt 311412, sn: (b)(4)) and a type 1a endoleak.On (b)(6) 2022 a reintervention was performed.As reported, the physician obtained bilateral wire access and ballooned the proximal end of the gore® excluder® aaa trunk ipsilateral endoprosthesis (rlt 311412, sn: (b)(4)).Intravascular ultrasound (ivus) was performed and it was observed that the endoprosthesis appeared fully open.A gore® excluder® conformable aaa aortic extender endoprosthesis, cxa320005, was placed at the proximal end of the gore® excluder® aaa trunk ipsilateral endoprosthesis (rlt 311412, sn: (b)(4)) increasing seal length to just below the left renal artery.As reported, it was observed via angiogram that there appeared to be resolution of the type 1a endoleak.

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 april 27th, 2022 - engineering evaluation was completed in full on the specified date.H6: code 4315, cause not established - the imaging evaluation showed the following: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.Imaging summary: one non-dicom movie submitted for evaluation.No name, date, or demographics on movie images.Images appear to show a collapsed proximal device.There appears to be contrast within the device and outside the device, thereby, confirming a type i endoleak.There appears to be seal of the distal device limbs, with available images.H6: code 4315, cause not established - engineering reviewed all available information regarding the compression.The evaluation indicated the following: the device evaluation was performed based on what was reported to gore and images, including an imaging evaluation, attached to the event as the device was not returned for analysis.Based on the imaging evaluation, the physician¿s observation that the trunk of the trunk-ipsilateral leg component had collapsed appears to be confirmed.The physician¿s observation of a type 1a endoleak also appears to be confirmed.The likely cause for the reported observation that the trunk had collapsed and the type 1a endoleak could not be determined with the available information.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 b5, describe event or problem.There was a typo in the description summary related to the device product number.Note that this was correctly indicated elsewhere in the report.Instead of rlt 311412, sn: (b)(6), it should have indicated rlt 311413, sn: (b)(6).

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13588269
• MDR Text Key: 290465109
• Report Number: 3007284313-2022-01787
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132619078
• UDI-Public: 00733132619078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2020
• Device Model Number: RLT311413
• Device Catalogue Number: RLT311413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2017
• 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
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male