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	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Aneurysm (1708); Vascular Dissection (3160)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment for an abdominal aortic dissection and a left common iliac artery (lcia) aneurysm.The patient was implanted with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses (ibe).The patient tolerated the procedure.On (b)(6) 2023, follow-up computed tomography angiography showed the lcia had dilated to 26mm in diameter.Additionally, a distal type i endoleak had developed involving the contralateral leg component (plc231200) originally implanted.On (b)(6) 2023, the patient underwent re-intervention and an additional ibe device was implanted within the plc231200 limb.The left internal and ibe were connected using a 11x59 mm vbx stent.The left external was extended using a plc201000 limb since the external measured 17.5 mm.The procedure was well tolerated and without complication.
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprostheses states; adverse events that may occur and / or require intervention include but are not limited to: endoleak patient medical history includes but is not limited to: arthritis, back pain, diverticulitis, gerd, hepati cirrhosis, hernia, hypo thyroid, hld, nephrolithiasis patient medications include but are not limited to: acetaminophen, apixaban, ascorbic acid, atorvastatin, carvedilol, cetirizine, coenzyme q10, fluticasone 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.

• 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: 16485628
• Report Number: 3013164176-2023-01628
• Device Sequence Number: 12237131
• Product Code: MIH
• UDI-Device Identifier: 00733132618569
• UDI-Public: 00733132618569
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2023

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: 06/04/2021
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/06/2023
• Date Device Manufactured: 06/05/2018
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 113 KG