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

Model Number	PLC141400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pll161407/(b)(4) udi (b)(4).Patient medications: aspirin, clopidogrel, heparin, acetaminophen and oxycodone.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 information was reported to gore through the pivotal study for the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device): on (b)(6) 2020, the patient was implanted with two gore® contralateral leg endoprostheses, a gore® iliac branch endoprosthesis and the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).Two gore® dryseal flex introducer sheath¿s were used for the procedure.The patient was being treated for an aortic aneurysm involving the visceral vessel(s).It was reported that on (b)(6) 2020, images revealed the patient had a distal left common iliac dissection.It is unknown which gore® dryseal flex introducer sheath was used in the left common iliac artery.Further investigation is being conducted.The adverse event is ongoing.
Additional Manufacturer Narrative
H6: added component code g04122.H6: updated investigation findings code from 3233 to c19, a review of the manufacturing records indicated the lot met pre-release specifications.H6: updated investigation conclusion code from 11 to d15.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, dissection, perforation, or ruptures of the aortic vessel and surrounding vasculature.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14794865
• Report Number: 3013164176-2022-01411
• Device Sequence Number: 5935368
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: 00733132618651
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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: 04/07/2023
• Device Model Number: PLC141400
• Device Catalogue Number: PLC141400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 69 KG