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

Model Number	RLT351418
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On an unspecified date the patient presented with abdominal/groin pain.Computed tomography angiography (cta) was performed and revealed migration of a previously implanted gore® excluder® aaa endoprosthesis (rlt351418), and a proximal type 1 endoleak.As reported, the previously implanted rlt rlt351418 had migrated 9.5 centimeters and the identified cause was ongoing disease progression with aortic neck dilation.The aneurysm was observed to have grown approximately 8 centimeters in diameter.On (b)(6) 2022 a reintervention was performed.The physician elected to use a gore® tag® conformable thoracic stent graft with active control system (ctag ac, catalog#: tgmr404010) to contain a rupture of the aneurysm.As reported, the ctag ag was used in an unspecified off-label manner.Reportedly, the type i endoleak was contained.The patient was observed to be doing well.The physician does not require any follow-up on this case.No images are available for consideration.
Additional Manufacturer Narrative
While there was no device return an evaluation was performed with the available provided information.According to the engineering evaluation: 1) without a physical sample or images to evaluate, the physician¿s observation that there was a type i endoleak, 9.5 centimeter migration, and a rupture of the aneurysm, could not be confirmed.2)the likely cause for the reported type i endoleak, 9.5 cm migration, and rupture of the aneurysm could not be determined with the available information.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 was updated to 30-aug-2022, as the additional engineering evaluation results were received on this date.
Additional Manufacturer Narrative
This event is both a product malfunction and a serious injury so both have been indicated in section b1.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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: 14453367
• Report Number: 3007284313-2022-01924
• Device Sequence Number: 11899280
• Product Code: MIH
• UDI-Device Identifier: 00733132618491
• UDI-Public: 00733132618491
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2019
• Device Model Number: RLT351418
• Device Catalogue Number: RLT351418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 08/30/2022; 08/30/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/30/2022; 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male