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

Catalog Number RLT231412

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

B7: patient medical history includes but is not limited to: hypertension, peripiheral vascular diesease.D10: patient medications include but are not limited to: tylenol, aspirin, lipitoroxyeutynln p, wellbutrin, zyrtec, chlorthalldone, cyanocobalamin, donepezil, fluticasone, llelnopril, montalukast, primidone, sertraline, tamsulosin, miconazole.The instructions for use (ifu) specifies, the safety and effectiveness of the gore®excluder®aaa have not been evaluated in the following patient populations: revision of previously placed stent grafts.Additionally, the ifu specifies, adverse events that may occur and / or require intervention include but are not limited to: endoleak, endoprosthesis: migration.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 Description

On (b)(6) 2015, this patient underwent endovascular treatment of a prior endovascular repair with a medtronic afix graft and a vela cuff.Gore® excluder®aaa endoprosthesis were implanted to treat a proximal type i endoleak due to suspected migration of the medtronic devices.Pre-treatment maximum aortic diameter measured 52mm.On an unknown date estimated to be on or about (b)(6) 2023, the patient was determined to have a right common iliac artery aneurysm (rciia) and a proximal type i endoleak due to suspected migration of the proximal grafts.On (b)(6) 2024, the patient underwent additional endovascular of a suspected proximal type and treatment of the rciaa, two gore® excluder® aortic extenders were implanted proximally and the rciaa was coil embolized and extended distally with a gore® excluder® endoprosthesis.The patient tolerated the procedure with no endoleak confirmed, and was discharged from the hospital on (b)(6) 2024 in stable condition.

Manufacturer Narrative

H6: added code.

• 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19102270
• MDR Text Key: 340104398
• Report Number: 2017233-2024-04816
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622368
• UDI-Public: 00733132622368
• 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: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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
• Device Expiration Date: 05/17/2018
• Device Catalogue Number: RLT231412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Race: White