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

Model Number	PLC181200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to endoleak and aneurysm enlargement.As gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: device part number: plc201400, device s/n: (b)(4), device description: gore® excluder® aaa endoprosthesis, stent graft contralateral leg.
Event or Problem Description
On (b)(6) 2018 the patient was implanted with gore® excluder® aaa trunk ipsilateral endoprosthesis, rlt311413 (b)(4), and two gore® excluder® aaa contralateral leg endoprostheses, plc181200 (b)(4) and plc201400 (b)(4) for an unspecified diagnosis.On (b)(6) 2021 the patient was implanted with gore® excluder® aaa endoprostheses plc231000 (b)(4) and a plc271000 (b)(4).As reported, a type 1b endoleak was observed and the gore® excluder® aaa plc271000 (b)(4) was implanted in order to treat the endoleak.The details of this procedure were requested but remain unknown.It was requested but is unknown which side of the body the endoleak was observed on and therefore which endoprosthesis it is related to.
Additional Manufacturer Narrative
G3/g4: added pma/510(k) number.
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.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to endoleak and aneurysm enlargement.B7: information regarding pre-existing medical conditions was requested but was not provided.It was indicated that the patient was transferred to the current physician and a complete history was not available.D8/d9: specified that the device was not serviced by a third party.G3/g4: imaging review was completed on february 28th, 2022.Manufacturing record review was completed on march 1st, 2022.H3: the medical device remains implanted, and was therefore not available for evaluation.H6: 213, no device problem found - a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H6: 4315, cause not established - results of investigation were unable to confirm the most likely cause.Imaging evaluation summary: images provided are dated (b)(6) 2021, (post reintervention in (b)(6) 2021) images are pre-contrast and arterial phase.There is contrast outside of the implanted device on the arterial phase.There are patent lumbars present.There is a lack of wall apposition at the distal end of the graft on the left.There is contrast outside of the device at the distal end of the graft on the left.Findings consistent with a distal type 1 endoleak on the left.H8: specified that event was related to the initial use of the device as this was unspecified in the original submission.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13538257
• Report Number: 3013164176-2022-01301
• Device Sequence Number: 4073620
• Product Code: MIH
• UDI-Device Identifier: 00733132618736
• UDI-Public: 00733132618736
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2022

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: 05/30/2021
• Device Model Number: PLC181200
• Device Catalogue Number: PLC181200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/01/2022; 06/17/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/08/2022; 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• 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; Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male