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

Catalog Number RLT351414

Device Problem Migration (4003)

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

Event Date 04/19/2024

Event Type  Injury  

Manufacturer Narrative

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: endoprosthesis: migration, surgical conversion patient medications include but are not limited to: zyloprim 300mg, lipitor 40mg, zyrtec 5mg, colace 50mg and prilosec 40mg.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) 2018, this patient underwent endovascular treatment for a zone 9 infrarenal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2024, the patient underwent reintervention to treat migration distal migration of 13cm the (distal to the lowest renal artery) of the proximal trunk.The physician¿s intended treatment plan was to re-line the c3 trunk with a gore® excluder® conformable aaa endoprostheses, however wire access through the originally implanted c3 graft was unable to be achieved.The physician chose to abort the procedure to reline and schedule explant of the devices.Tortuosity of the patient¿s iliac arteries was reported to have contributed to the inability to gain wire access through the originally implanted c3 trunk device.The patient tolerated the procedure.A date for explant has not yet been scheduled.The cxt device was not part of this procedure, it had not been prepped or removed from it¿s packaging.

Manufacturer Narrative

The imaging evaluation performed by a clinical imaging specialist showed the following: one time-point available for evaluation: post-implantation cta dated on (b)(6) 2024.3d images show the proximal implanted device has moved distally from intended position by 10mm, between 2018 implant date to present.There appears to be significant thrombus throughout the abdominal aorta distal to the left renal artery.Aortic diameter just distal to the left renal artery is ~31mm.Aortic diameter ~8mm distal to the left renal artery is 33.4mm.Aortic diameter 15mm distal to the left renal artery is 35.0mm.3d images show tortuosity in the common iliac arteries, bilaterally.Product investigation report conclusion - the complaint information reports migration of the proximal trunk approximately 13cm from the original implant position.An imaging evaluation of the post-implant ct scan confirmed that the gore® excluder® aaa endoprosthesis trunk ipsilateral limb migrated 10mm.Additionally, the imaging evaluation showed that the aortic diameter measurements were outside of the intended aortic inner diameter range for a 35mm device.The measurements throughout the proximal landing zone ranged from 31-35mm, which is greater than the 30-32mm intended aortic inner diameter range.Aortic diameter measurements from the index procedure of the excluder device were not available, and a causal relationship between the device migration and aortic diameters could not be established.The findings of device migration were consistent with the description summary.The root cause of the confirmed device migration could not be determined.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19169394
• MDR Text Key: 340899505
• Report Number: 3007284313-2024-03195
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618477
• UDI-Public: 00733132618477
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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: 03/31/2019
• Device Catalogue Number: RLT351414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 88 KG