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

Model Number	PLC161200
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Code d12: the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, embolization micro and macro w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2023, bilateral type i distal endoleaks were reported for the patient.The physician plans to reintervene on (b)(6) 2023 and implant bi-lateral extensions and embolize the left internal iliac artery.
Additional Manufacturer Narrative
H6 code f1901-reintervention surgery was performed.Gore fsa (field sales associate) reported reintervention surgery was performed on (b)(4) 2023.Patient medication was provided and are as follows: aspirin, lipitor, cardizem, tikosyn, synthroid, lopressor, prilosec, effexor h6 code e2121- code has been updated to reflect endoleak.Code (b)(6)-code has been updated to reflect issue reported.Code b20-updated to reflect device remains implanted and is not available for return.
Event or Problem Description
On (b)(6), 2019, this patient underwent endovascular treatment and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6), 2023, bilateral type i distal endoleaks were reported for the patient.The endoleaks were identified within the contralateral leg components.The physician planned to reintervene on (b)(6), 2023 and implant bi-lateral extensions and embolize the left internal iliac artery.It was later reported that on (b)(6), 2023, the physician performed reintervention surgery in which bi-lateral extensions were implanted and the left internal iliac artery was embolized.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16376444
• Report Number: 3013164176-2023-01610
• Device Sequence Number: 20354035
• Product Code: MIH
• UDI-Device Identifier: 00733132618705
• UDI-Public: 00733132618705
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 04/15/2022
• Device Model Number: PLC161200
• Device Catalogue Number: PLC161200
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 89 KG