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

Model Number	PLC121200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported the following comorbidities and medications were provided comorbidities - dyslipidemia, hypertension, diabetes, hypercalcemia, smoker.Medications - norco, ativan, neurontin, vitamin d, prinivil, glucophage, zocor, tylenol as gore was unable to determine which device (s) caused or contributed to the event if any; additional device(s) implanted related to this event include th following gore® excluder® aaa endoprosthesis, stent graft contralateral leg (plc1410000), lot/serial - (b)(4), udi: (b)(4).Gore® excluder® aaa endoprosthesis, stent graft iliac extender (pll1614070), lot/serial: (b)(4), udi: (b)(4).(b)(4).
Event or Problem Description
On (b)(6), 2022 the patient underwent evar for an abdominal aortic aneurysm and was implanted with the following gore endoprostheses: cxt261412 (lot/sn:(b)(4)) gore® excluder® conformable aaa endoprosthesis - trunk ipsilateral leg; plc121200 (lot/sn: (b)(4)) gore® excluder® aaa endoprosthesis - contralateral leg; plc141000 (lot/sn: (b)(4)) gore® excluder® aaa endoprosthesis - contralateral leg; pll161407 (lot/sn: (b)(4)) gore® excluder® aaa endoprosthesis - iliac extender.At the one month follow up visit ct imaging revealed stenosis in the right limb.This was reportedly the result of the previously implanted stents competing for space within the small vessel area (1000-e:-other).As reported, the patient was asymptomatic.On (b)(6), 2022 the patient underwent a planned reintervention in which gore® viabahn® vbx balloon expandable endoprosthesis devices were implanted in the right limb.The left side was accessed, but only to place a balloon in order to counteract the stent inflation (kissing balloon technique).As reported, the patient tolerated the procedure.Information regarding which endoprostheses went down the right leg and which went down the left leg was requested but was not provided and remains unknown.
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.H6: code 213, no device problem found ¿ a review of manufacturing records verified that the lot involved in this event met all pre-release specifications.H6: code 22, known inherent risk of device - according to the gore® excluder® aaa endoprosthesis ifu, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: occlusion of device or native vessel.Also according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), all lengths and diameters of the devices necessary to complete the procedure should be available to the physician, especially when pre-operative case planning measurements (treatment diameters / lengths) are not certain.This approach allows for greater intraoperative flexibility to achieve optimal procedural outcomes.Additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair, and freedom from significant femoral / iliac artery occlusive disease that would impede inflow or outflow of stent-grafts.Successful patient and device selection is dependent on knowledge of radiographic image interpretation, device selection and sizing.Recommended endoprosthesis oversizing relative to the vessel is approximately 7-25% for contralateral leg and iliac extender components.

• 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: 13995742
• Report Number: 3013164176-2022-01344
• Device Sequence Number: 5104319
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/19/2022

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: 07/24/2024
• Device Model Number: PLC121200
• Device Catalogue Number: PLC121200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 89 KG