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

Catalog Number	PLC271400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D.10.Concomitant medical products and therapy dates: ramipril, eliquis, plavix, metoprolol, lasix, protonix, vitamin d, atorvastatin.H.6.Type of investigation: code b15 - images were provided, and an imaging evaluation will be performed.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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, endoleak.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), 2021, the patient underwent endovascular treatment of an abdominal aortic aneurysm and bilateral common iliac artery aneurysms using gore® excluder® aaa endoprostheses.It was reported that the patient's common iliac artery tapered from 23mm to 15mm and, during case planning, it was determined that the patient's right internal iliac artery may require coiling and coverage in order to obtain seal.However, after discussions, the physician and patient opted to keep the internal iliac artery patent and monitor the implanted limb.Therefore, a contralateral leg component was implanted in the patient's right common iliac artery and ended approximately 15mm from the patient's right internal iliac artery.There were no reported issues at the close of the procedure and the patient tolerated the procedure.During follow-up on an unknown date, a distal type i endoleak was observed on the contralateral leg component in the patient's right limb.On (b)(6), 2023, the patient underwent reintervention.The patient's internal iliac artery was coiled.An iliac extender component and an additional contralateral leg component were used to extend the right limb distally and obtain aneurysm exclusion.The distal type i endoleak was successfully treated.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Investigation findings for imaging evaluation: the imaging evaluation, performed by a clinical imaging specialist, showed that one time-point was available for evaluation: post-implantation cta dated (b)(6) 2023.Images showed a lack of distal limb apposition in the right common iliac (rci).Contrast was visualized outside the implanted devices.The contrast was visualized flowing into the abdominal aortic aneurysm sac from the rci, thereby confirming a distal type i endoleak.Rci diameters appeared to range from approximately 21.3mm - 33.7mm.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, endoleak.H.6.Investigation findings for imaging evaluation: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d1001.

• 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: 17909651
• Report Number: 3013164176-2023-01862
• Device Sequence Number: 17836940
• Product Code: MIH
• UDI-Device Identifier: 00733132618606
• UDI-Public: 00733132618606
• 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: 2021
• 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): 11/11/2023

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: 12/01/2022
• Device Catalogue Number: PLC271400
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 FOR LIST OF MEDICATIONS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 72 KG