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

Model Number	PLC231400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprostheses instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak.
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment of bilateral iliac artery aneurysms using gore® excluder® aaa endoprostheses.On (b)(6) 2020, follow up ct revealed a dissection proximal to the celiac artery and a type 3 disconnect endoleak and type 1b endoleak on the right side.It was reported that during the original procedure on (b)(6) 2019, there was difficulty snaring the guidewire, which might have led to wire trauma in the aorta, causing or contributing to a dissection.This was reported to fda on mfr report # 3007284313-2019-00143.On (b)(6) 2020, the physician treated the dissection with a 36 mm aortic extender component that covered the fenestration.However, during deployment of the aortic extender, the device was inadvertently deployed over the soft portion of the guidewire, which caused the delivery catheter to rotate and move distally during deployment, and the celiac artery was partially covered.The physician then cannulated the celiac artery and deployed an 8x20 mm gore® viabahn® vbx device and extended proximally in the aorta with another 36 mm aortic extender component.The type 3 endoleak between the ceb endoprosthesis and the plc231400 in the right limb was treated with a plc271400 contralateral leg component.The type 1b was treated with an 8x59 gore® viabahn® vbx successfully.(the ceb portion of this event was reported to the fda on mfr report # 3007284313-2020-01023) the patient tolerated the procedure.

• 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
• MDR Report Key: 11032710
• Report Number: 3007284313-2020-01199
• Device Sequence Number: 11078969
• Product Code: MIH
• UDI-Device Identifier: 00733132618583
• UDI-Public: 00733132618583
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: 11/08/2021
• Device Model Number: PLC231400
• Device Catalogue Number: PLC231400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR