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

Catalog Number	PXT261414
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was obtained from program and abstracts of the 29th annual meeting of the japanese society of endovascular intervention.Norihiro ando, et al.Four cases that required open surgery after endovascular aortic repair.The authors report on 4 cases of aneurysm enlargement or rupture due to endoleak (el) following endovascular aortic repair (evar) that required open surgery.The cases were four male patients in their 70s or 80s.Two were treated with gore® excluder® aaa endoprosthesis and the other two were treated with medtronic endurant.In 2 excluder cases and 1 endurant case, aneurysm enlargement due to type ii el occurred, and transarterial lumbar artery embolization and percutaneous lumber artery embolization were performed; however, the enlargement continued and thus, surgical aneurysmorrhaphy was performed.After the surgery, aneurysm shrinkage was shown in 2 cases.Although further enlargement was noted in 1 case, it stopped 2 years later.
Additional Manufacturer Narrative
H.6.Type of investigation code b20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c21: investigation pending confirmation that serial number is not available.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.
Additional Manufacturer Narrative
H.6.Investigation findings code c19: the device remains implanted and is not available for analysis.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusions code d12: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Specifically, the ifu warns that adverse events that may occur and / or require intervention include, but are not limited to endoleak.D4: catalog number, expiration date, serial number, and udi added.D6a: implant date added.G - manufacturing site: name and address corrected.G3: date received is july 27th, 2023, as that is the date that the individually identifying information was obtained for the patients in the literature article.H.4.Date of manufacture added.H.6.Type of investigation code b14 added h.6.Investigation findings code c21 changed to c19 h.6.Investigation conclusions code d16 changed to d12.H.6.Investigation conclusions code d15 added.

• 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 WOODY SPRINGS; 3450 w kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17398010
• Report Number: 3007284313-2023-02660
• Device Sequence Number: 5931434
• Product Code: MIH
• UDI-Device Identifier: 00733132610228
• UDI-Public: 00733132610228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2009
• Device Catalogue Number: PXT261414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2006
• 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: Required Intervention
• Patient Sex: Male