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

Model Number RLT281412

Device Problem Fluid/Blood Leak (1250)

Event Date 12/15/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, occlusion of device or native vessel, rupture.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 an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis.Follow-up ultrasound on (b)(6) 2015 reported the maximum diameter of aortic aneurysm/lesion (mm) measured 52mm.Follow-up ultrasound on (b)(6) 2015 reported the maximum diameter of aortic aneurysm/lesion (mm) measured 85mm and a new endoleak (type not identified).On (b)(6) 2023, a reintervention is planned wherein possible coiling of an accessory vessel related to the endoleak may be performed.

Event Description

On (b)(6) 2023 follow-up computed tomography angiography (cta) measured the sac at 8.7 x 8.3 and reported ¿a small type-2 endoleak¿.A gore representative (at our request) reviewed films extensively, and stated that he could not discern any leak.The patient is asymptomatic and 93 year old and has expressed some doubt that he would want to have any further reinterventions, but is scheduled for reintervention on (b)(6) 2023.

Event Description

On (b)(6) 2023, the patient underwent endovascular re-intervention wherein coil embolization of the filling lumbar branches to the aortic sac was performed.Completion arteriogram of the hypogastric artery showed no further communication of the lumbar branches to the a aneruysm sac.The patient tolerated the procedure.

Manufacturer Narrative

B4: additional information.

• 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: 16080870
• MDR Text Key: 306495759
• Report Number: 2017233-2022-03612
• 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: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/31/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2018
• Device Model Number: RLT281412
• Device Catalogue Number: RLT281412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 12/16/2022; 12/16/2022; 12/16/2022
• Supplement Dates FDA Received: 01/30/2023; 03/03/2023; 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2015
• 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): Required Intervention; Hospitalization; Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 88 KG