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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #ceb231410a/ serial #(b)(4)/ udi #(b)(4).Catalog #ceb231210a/ serial #(b)(4)/ udi #(b)(4).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
On (b)(6) 2018, the patient underwent endovascular treatment of bilateral iliac artery aneurysms using gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.On (b)(6) 2022, the patient underwent reintervention for a type iii endoleak in the left common iliac artery.Reportedly, the gore® excluder® iliac branch component had separated from the contralateral leg component on the patient's left side.Aneurysm enlargement was also observed (amount unknown).It was noted that a gore representative was not present at the case.Cause of the component separation is unknown.It was reported that access was gained via the patient's arm and multiple (quantity unknown) gore® viabahn® endoprostheses and gore® viabahn® vbx balloon expandable endoprostheses were used in the patient's left internal and left common iliac arteries in a kissing technique to reline the separated devices.No gore® excluder® internal iliac component was located in the patient's left internal iliac artery.The reintervention was reportedly successful and the endoleak was successfully treated.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d12 added.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 or additional intraoperative procedure time include, but are not limited to, component migration, endoleak, and aneurysm enlargement.According to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, component migration, endoleak, and aneurysm enlargement.The ifu also instructs users to visually verify that the distal contralateral leg radiopaque marker is aligned with the proximal edge of the long and short radiopaque markers of the iliac branch component prior to device deployment.Alignment of these markers will achieve an approximate 3 cm overlap.H.6.Investigation findings: code c21 updated to code c19 h.6.Investigation conclusions: code d16 updated to code d15.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16076132
• Report Number: 3013164176-2022-01581
• Device Sequence Number: 6186744
• Product Code: MIH
• UDI-Device Identifier: 00733132618569
• UDI-Public: 00733132618569
• 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
• 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): 02/09/2023

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: 11/30/2018
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2015
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male