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

Model Number	PXT231416
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at the time of event/date of birth: asked but unavailable.Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.
Event or Problem Description
On (b)(6) 2009 the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On an unknown date, proximal migration (distance unknown) of the ipsilateral leg of the trunk-ipsilateral leg component located on the patient's right side, and aneurysm enlargement (amount unknown) were observed.The physician stated that approximately 10 years after the initial procedure it was noted that the vessel diameter where the ipsilateral limb was located had enlarged, and the limb migrated.On (b)(6) 2020 the patient underwent reintervention.A gore® excluder® aaa contralateral leg component was used to extend the ipsilateral leg distally.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Conclusions code 2: code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, component migration, dilatation, and aneurysm enlargement.

• 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
• MDR Report Key: 10460907
• Report Number: 2953161-2020-01012
• Device Sequence Number: 19555548
• Product Code: MIH
• UDI-Device Identifier: 00733132610150
• UDI-Public: 00733132610150
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: 02/29/2012
• Device Model Number: PXT231416
• Device Catalogue Number: PXT231416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention