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

Model Number	PXC121200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The following was reported to gore by clinical specialist.On (b)(6) 2015, patient underwent an unknown procedure utilizing two gore excluders rlt281414 (right) and pxc121200 (left).Prior to the implant in 2015, patient suffered from right lower extremity ischemia due to embolization from abdominal aortic aneurysm.Patient also diagnosed with lung cancer that radiology/oncology refused to treat until aneurysm was addressed.According to the physician, the aortic anatomy was not ideal for endovascular repair but was likely patient¿s best option considering comorbidities and urgency to begin cancer treatment.Patient had short, reverse tapered neck with the aortic diameter at the renals was 18mm and quickly dilated to ~30mm over 12mm length.During a follow-up sometime in (b)(6) 2022 (date unknown), the patient presented with graft migration / disease progression proximal edge of the graft migrated down (distally) at the level of the renals and did not cover the renals.Aortic diameter at renals had grown to 4-5cm.The original graft migrated ~3cm.On (b)(6) 2022, the patient was treated with open repair; graft explant was performed.Procedure was successful with no harm to the patient.Post-surgery follow-up date is unknown.The explanted graft was not saved for return.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h7, and h10/h11."review of the file determined this event to be non-reportable, as no patient adverse events, or other serious injury has been reported and this was a planned open surgical procedure".Therefore, this medwatch will be voided.".

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16040544
• Report Number: 2953161-2022-01164
• Device Sequence Number: 4897009
• Product Code: MIH
• UDI-Device Identifier: 00733132609925
• UDI-Public: 00733132609925
• 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: 2015
• Device Explanted Year: 2022
• 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): 01/19/2023

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: 06/30/2017
• Device Model Number: PXC121200
• Device Catalogue Number: PXC121200
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female