MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	PLC181400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: plc181000, lot#: 17372341, udi: (b)(4); product id: plc231000, lot#: 17628965, udi: (b)(4).It is not known which device exhibited the type ib endoleak, therefore all are being investigated.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient underwent treatment of an abdominal aortic aneurysm measuring 51.6mm, with a gore® excluder® conformable aaa endoprosthesis and gore® excluder® aaa endoprostheses.On (b)(6) 2019 the maximum aortic diameter was 56mm.On (b)(6) 2020 the maximum aortic diameter was 64mm.On (b)(6) 2020 a type ib endoleak was discovered and treated by means of an additional unknown peripheral stent graft.
Additional Manufacturer Narrative
Section d updated.Plc181000 lot# 17372341 udi: (b)(4) was the device confirmed to be associated with the reported event.H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Conclusion code 1: 22: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleaks.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 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 an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.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: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10136379
• Report Number: 3013164176-2020-00080
• Device Sequence Number: 3184085
• Product Code: MIH
• UDI-Device Identifier: 00733132618699
• UDI-Public: 00733132618699
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 10/23/2020
• Device Model Number: PLC181400
• Device Catalogue Number: PLC181000
• Device Lot Number: 17372341
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H.10./11.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 114