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

Model Number	PLC201400
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	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to gore that a gore® excluder® aaa endoprostheses was used to treat a patient with an abdominal aortic aneurysm.The surgeon accidentally covered the left common iliac artery with the stent (plc201400).It was reported that the surgeon did not try to correct the coverage.No patient consequences was reported.
Additional Manufacturer Narrative
Concomitant medical products: gore® excluder® aaa endoprosthesis stent graft trunk ipsilateral leg c3 endoprosthesis (rlt281412, 24226877 (right side)).Gore® excluder® aaa endoprosthesis stent graft contralateral leg endoprosthesis (plc271000, 24109078 (right)).Gore® excluder® aaa endoprosthesis stent graft iliac extender endoprosthesis (pll161407, 23449359 (left)).(b)(4).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.
Additional Manufacturer Narrative
B5: update describe event or problem.Images was requested but not provided.Corrected h6: updated investigation conclusions code from 4311 to 61 - unintended use error caused or contributed to event.Code 4311 should be removed as it was inadvertently entered.
Event or Problem Description
It was reported to gore that a gore® excluder® aaa endoprostheses was used to treat a patient with an abdominal aortic aneurysm.The surgeon accidentally covered the left internal iliac artery with the stent (plc201400).It was reported that the surgeon did not try to correct the coverage and the cause of the accidental coverage is unknown.No patient consequences was reported.

• 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: 14392191
• Report Number: 3013164176-2022-01372
• Device Sequence Number: 20511909
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• 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: 2022
• 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): 06/09/2022

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: 11/19/2023
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male