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

Catalog Number	PXT281418
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On october 13, 2009, this patient underwent an endovascular procedure and was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.On october 14, 2022, follow-up computed tomography imaging identified a type 1a endoleak.A reintervention had reportedly been scheduled for (b)(6) 2023 to solve the situation.Gore has not yet received feedback if the reintervention was performed as planned.
Additional Manufacturer Narrative
H3, other code: the device remains implanted.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
B5, describe event or problem: updated description d4: the following was updated: serial number, expiration date, catalog number, unique identifier (udi) # h4/h5: device manufacture date: updated.Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.H6: code c19 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.Medical images were requested but were not provided to gore for evaluation.This complaint was initiated based on information received from the field.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Therefore, the cause of the reported type 1a endoleak could not be independently confirmed during the investigation.The available information reported does not reasonably suggest a potential malfunction has occurred.Reported type 1a endoleak represents a known complication or adverse event that can occur when using the gore® excluder® aaa endoprosthesis and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen and patient-related risk factors.No allegation of device malfunction was indicated with respect to device performance.No further information was provided to gore.Based on the incident description and the subsequent investigation, gore is unable to determine the cause of this incident and to assign a root cause.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), complications associated with the use of the gore® excluder® aaa endoprosthesis may include but are not limited to: endoleaks.
Event or Problem Description
On (b)(6) 2009, this patient underwent an endovascular procedure and was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.On (b)(6) 2022, follow-up computed tomography imaging identified a type 1a endoleak.An enlargement of the aneurysm was not reported.On (b)(6) 2023, a reintervention was performed and the endoleak was successfully solved.The patient tolerated the procedure.
Additional Manufacturer Narrative
Section g: contact office - manufacturing site: updated manufacturing plant address.

• 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 SUNNYVALE; 1327 orleans dr; sunnyvale CA 94089
• Manufacturer Contact: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18181638
• Report Number: 3007284313-2023-02897
• Device Sequence Number: 18034412
• Product Code: MIH
• UDI-Device Identifier: 00733132610327
• UDI-Public: 00733132610327
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: PXT281418
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 02/20/2024; 02/22/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/21/2024; 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2009
• 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
• Patient Weight: 85 KG