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

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Unspecified Infection (1930); Obstruction/Occlusion (2422)

Event Date 01/01/2022

Event Type  Injury  

Event Description

The following was reported to gore via voluntary user facility medwatch report #mw5144550: on an unknown date, the patient presented with a gore® excluder® aaa endoprosthesis with right limb occlusion.On an unknown date in 2022, there was an attempt to recanalize the right limb occlusion.On an unknown date, femoral to femoral bypass was performed for non salvageable limb occlusion.On an unknown date, the patient was referred to dr.(b)(6) for a fem-fem graft infection with groin abscess.

Manufacturer Narrative

Additional devices included on this report are as follows: gore® excluder® aaa endoprosthesis contralateral leg component catalog #unk/ serial #unk/ udi #unk a.1.Patient identifier: this information has been requested but has not yet been provided to gore.A.2.Age at the time of event/date of birth: this information has been requested but has not yet been provided to gore.A.3.Gender: this information has been requested but has not yet been provided to gore.A.4.Patient weight: this information has been requested but has not yet been provided to gore.B.3.Date of event: as the date of reported device occlusion is unknown, but a reintervention attempt was reported on an unknown date in 2022, the date of event has been estimated as january 1, 2022.B.7.Other relevant history, including preexisting medical conditions: this information has been requested but has not yet been provided to gore.D.4.Device information: the device lot/serial number has been requested but has not yet been provided to gore.D.6a.If implanted, give date: date of device implant remains unknown.D.10.Concomitant medical products and therapy dates: this information has been requested but has not yet been provided to gore.H.4.Device manufacture date: as the device lot/serial number has been requested but has not yet been provided to gore, the device manufacture date remains unknown.H.6.Type of investigation: code b22 - as the device lot/serial number has been requested but has not yet been provided to gore, no device history record review was able to be completed.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

H.6.Health effect - clinical code: e2328 remains unchanged h.6.Health effect - clinical codes: e1906 and e172001 have been removed as infection and groin abscess are reported on the fem-fem graft and unrelated to the gore graft.

Manufacturer Narrative

Investigation conclusions: according to the gore® excluder® aaa endoprosthesis instructions for use, 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, occlusion of device or native vessel.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17873299
• MDR Text Key: 324961628
• Report Number: 3007284313-2023-02803
• Device Sequence Number: 1
• Product Code: MIH
• 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: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2024

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 02/23/2024; 02/23/2024
• Supplement Dates FDA Received: 02/23/2024; 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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