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

Model Number	PXC201400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: code "other" was selected as the medical device remains implanted.Return not possible.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 or Problem Description
On (b)(6) 2010, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.A trunk, ipsilateral leg endoprosthesis (pxt281212) was deployed, and its ipsilateral leg was extended by a contralateral leg endoprosthesis (pxc181000).Another contralateral leg endoprosthesis (pxc201400) was deployed as a contralateral limb.As the pxc201400 landed on a tightly curved left common iliac artery, it was reinforced by a cordis palmaz® stent.The final angiography confirmed a type ¿ endoleak, which was decided to be monitored and left untreated.The patient tolerated the procedure.(ref: (b)(4) on (b)(6) 2015, reintervention was performed to treat a proximal type endoleak.While securing the left renal flow by using a boston scientific express¿ vascular sd as a chimney graft, an aortic extender endoprosthesis was added to the proximal end of the previously implanted pxt281212.The final angiography confirmed no endoleaks.The patient tolerated the procedure.(ref: (b)(4).On an unknown date around 2021, a follow-up examination confirmed an unknown amount of aneurysm enlargement.As treatment, the patient underwent an open vascular graft replacement during which the previously implanted pxt281212, pxc181000 and pxc201400 were partially explanted.On an unknown date, a follow-up examination confirmed a distal type endoleak from the left contralateral limb where the pxc201400 had been implanted.On (b)(6) 2023, reintervention was performed to treat the observed distal type endoleak.After coil embolizing the left internal iliac artery with abbott amplatzer¿ vascular plug 4, two contralateral leg endoprosthesis (plc121400j+plc121000j) were added to the distal end of the left contralateral limb.The endoleak was resolved.The patient tolerated the procedure.
Additional Manufacturer Narrative
Manufacturing site information was corrected.

• 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 B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17037619
• Report Number: 3013164176-2023-01713
• Device Sequence Number: 12487182
• Product Code: MIH
• UDI-Device Identifier: 00733132610051
• UDI-Public: 00733132610051
• 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: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 03/31/2013
• Device Model Number: PXC201400
• Device Catalogue Number: PXC201400
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2010
• 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