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

Model Number	PLC271400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following medical information was provided: - medications: metoprolol, gabapentin, aspirin - comorbidities: hypertension, peripheral vascular disease, cerebral vascular disease.The medical device remains implanted and was therefore not available for return and evaluation.Results pending completion of investigation ¿ manufacturing evaluation results will be provided once they are completed.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2013 the patient was implanted with the below identified grafts (per medical device tracking).The ipsilateral leg component was implanted down the right side of the patient and the plc271400 contralateral leg endoprosthesis was implanted down the left side.(b)(4), rmt281414, gore® excluder® aaa endoprosthesis, stent graft trunk ipsilateral leg c3 (b(4) plc271400 - gore® excluder® aaa endoprosthesis, stent graft contralateral leg (b)(4) pxc121200 - gore® excluder® aaa endoprosthesis, stent graft contralateral leg on (b)(6) 2022 the patient underwent a scheduled reintervention.As reported, there was noted disease progression down into the left common iliac artery.There was no noted issue identified regarding gore devices.During the reintervention procedure, the left hypogastric was plugged and two limbs were used to extend the existing graft down the left side.Diagnostic images prior to the reinterventions were provided for consideration.Imaging confirmed the presence of a type i distal endoleak and that there was a lack of wall apposition in the lci.The patient tolerated the procedure.
Additional Manufacturer Narrative
G3/g4 date received by manufacturer 24-may-2022: on this date remaining evaluation activities were completed in full.H6: code 213, no device problem found: a review of manufacturing records verified that the lot involved in this event met all pre-release specifications.H6: code 22, known inherent risk of device: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to endoleak and aneurysm enlargement.H6: code 50, event related to patient condition: as reported, the patient¿s ongoing disease progression caused/contributed to the lack of device apposition.

• 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: cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14316997
• Report Number: 2017233-2022-02909
• Device Sequence Number: 11960775
• Product Code: MIH
• UDI-Device Identifier: 00733132618606
• UDI-Public: 00733132618606
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 05/25/2022

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: 01/31/2016
• Device Model Number: PLC271400
• Device Catalogue Number: PLC271400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2013
• 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: Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 120 KG