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

Model Number	PLC231200
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met pre-release specifications.The device remains implanted and therefore no product evaluation has been performed.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to occlusion of device or native vessel.
Event or Problem Description
It was reported to gore that a gore® excluder® aaa endoprostheses was selected to treat a patient with an abdominal aortic aneurysm.The left internal iliac artery was unintentionally covered when deploying the contralateral leg endoprosthesis plc231200.It was reported that the device was placed lower than intended.It is not reported whether the coverage lead to any patient harm.The patient is doing well and routine follow up will be carried out.
Additional Manufacturer Narrative
H6: component code 515 added.B1: adverse event selection 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12567045
• Report Number: 3013164176-2021-01248
• Device Sequence Number: 14307653
• Product Code: MIH
• UDI-Device Identifier: 00733132618569
• UDI-Public: 00733132618569
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/21/2022

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: 09/23/2023
• Device Model Number: PLC231200
• Device Catalogue Number: PLC231200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female