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

Model Number	PLC141400
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2022 the patient underwent emergent endovascular treatment of a ruptured abdominal aortic aneurysm using gore® excluder® conformable aaa endoprostheses.It was reported that a gore® excluder® aaa contralateral leg component was used to extend the ipsilateral limb of the trunk-ipsilateral leg component.Reportedly 3cm of device overlap was present between the ipsilateral limb and the contralateral leg component.No endoleak was noted at the close of the procedure.There were no reported issues.The patient tolerated the procedure.On (b)(6), 2022 it was reported that the patient was complaining of back pain.Upon further investigation it was determined that the contralateral leg component had migrated distally and a type iii endoleak was present.There was no suspected cause of the distal device migration.It was reported that there was a very slight overlap between the ipsilateral limb and the contralateral leg component to where the physician was able to advance a guidewire and perform a relining of the devices.The device overlap was relined using a plc181000 contralateral leg component.The type iii endoleak was reportedly resolved.There were no further reported issues.The patient tolerated the reintervention.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #: cxt361414/ serial #: (b)(4)/ udi #: (b)(4) which has been captured under manufacturer report #3007284313-2022-01788.Concomitant medical products and therapy dates: hydrocodone, metoprolol titrate, amlodipine (b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in patient populations including, but not limited to, pending rupture or ruptured aneurysms.Furthermore, the ifu states that potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoleak and component migration.
Additional Manufacturer Narrative
G.4.Pma/510(k)number 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13588490
• Report Number: 3013164176-2022-01310
• Device Sequence Number: 14482710
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: 00733132618651
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2024
• Device Model Number: PLC141400
• Device Catalogue Number: PLC141400
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/11 FOR LIST OF MEDICATIONS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 95 KG