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

Model Number	CXT201212
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient was admitted for treatment of an abdominal aortic aneurysm and was implanted with a gore® excluder® conformable aaa endoprosthesis trunk ipsilateral component and a gore® excluder® aaa endoprosthesis contralateral leg component.Over the following weekend the patient went to the emergency room, and it was identified that there was an occluded limb.A reintervention was performed on (b)(6) 2022.The reintervention involved a thrombectomy followed by the implantation of two gore® viabahn® vbx balloon expandable endoprostheses at the aortic bifurcation via kissing balloon technique in order to preserve blood flow.As reported, the occlusion occurred on the ipsilateral side.The cause for the needed reintervention was directly identified as the patient anatomy that narrowed greatly around the bifurcation.As reported the flow divider was later observed to have landed directly in the restricted area of the patient¿s anatomy.As reported, there was no more than approximately 1cm to a 1/2cm of space in one spot.It was indicated that following the initial treatment procedure on (b)(6) 2022, that the post-implantation imaging conducted showed that all vessels were patent and there was no cause for concern, so the procedure was concluded.As reported, the contralateral side of the patient looked great at both the initial and the reintervention procedure and there were no concerns on that side.Only the ipsilateral side and implant were involved in the reported event.The reintervention was successful, and the patient is doing fine.Imaging was not made available to gore for this investigation.
Additional Manufacturer Narrative
The following information was provided for medical history medications: atenolol, aspirin, hydrochlorothiazide (hctz).Pre-existing conditions: hypertension (htn).Surgical hx: none indicated in available charts.(b)(4).According to the gore® excluder® conformable 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: endoprosthesis occlusion.Also, according to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), for pre-treatment planning: determine accurate size of anatomy and proper size of trunk-ipsilateral and contralateral endoprostheses (tables 20 and 21) and aortic and iliac extender endoprostheses (tables 21 and 22).Use high resolution, non-contrast and contrast enhanced computerized tomography (ct / cta) at = 3 mm acquisition and reconstruction collimation.Use multiple view, digital subtraction angiography with a radiopaque marker catheter or spiral ct multi-planar reconstruction.For angiography, use correct imaging angulation (cranial-caudal, lateral-oblique) to accurately identify origin of branch vessel anatomy.Consider breath-hold technique to optimize digital subtraction angiography image quality.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14488357
• Report Number: 3007284313-2022-01931
• Device Sequence Number: 11964208
• Product Code: MIH
• UDI-Device Identifier: 00733132650989
• UDI-Public: 00733132650989
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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: 11/17/2023
• Device Model Number: CXT201212
• Device Catalogue Number: CXT201212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2020
• 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: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 80 KG