MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT231416
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Perforation (2001); Blood Loss (2597)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), indications for use and appropriate anatomy for use of the trunk-ipsilateral leg endoprosthesis includes a proximal aortic neck angulation of less than or equal to 60°.Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation, short proximal aortic neck and significant thrombus and/or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.The safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: patients with less than 15 mm in length or >60° angulation of the proximal aortic neck.Furthermore, the ifu states that potential adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, vascular trauma (e.G.Bleeding, rupture).
Event or Problem Description
On (b)(6) 2020 the patient underwent endovascular treatment of a 16.5cm abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The gore® dryseal flex introducer sheaths were successfully placed.Angiography was performed.The gore® excluder® aaa trunk-ipsilateral leg component was successfully advanced.The trunk main body was deployed with no reported issues.It was reported that cannulation of the contralateral leg gate was difficult due to patient anatomy.The patient's anatomy was reportedly extremely tortuous, with a short aortic neck and calcification present.Attempts to cannulate the contralateral leg gate were continued without success.Reportedly the trunk-ipsilateral leg component was fully deployed, with the ipsilateral limb located in the patient's right iliac artery.The physician advanced a soft wire from the patient's right side up and over the device bifurcation in an attempt to snare the contralateral leg gate, located on the patient's left side.The physician continued attempts to snare the contralateral leg gate.Reportedly difficulty was encountered due to tortuosity of the patient's anatomy and the wire stiffness.It was reported that there was difficulty with the soft wire remaining within the contralateral leg gate.A 32mm cook medical coda® balloon catheter was advanced up to the device bifurcation to provide stability within the contralateral leg gate.The balloon was reportedly inflated just above the patient's renal arteries.The physician was then able to push the soft wire down to the patient's left common iliac artery.The cook medical coda® balloon catheter was inflated further and locked down to hold pressure.The gore® excluder® aaa contralateral leg component was advanced.Imaging was performed, and rupture of the patient's proximal aorta was identified.The rupture was reportedly distal to the patient's renal arteries, and proximal to the trunk-ipsilateral leg component.It was reported that the rupture occurred at the time the cook medical coda® balloon catheter was inflated and locked down.The patient's blood pressure reportedly dropped.The contralateral leg component was quickly deployed.A full angiography run was performed, and leaking was noted on the patient's left side.Two 23mm gore® excluder® aaa aortic extender components were placed proximal to the trunk-ipsilateral leg component.Another angiography run was performed, and leaking was still noted.Two additional 26mm gore® excluder® aaa aortic extender components were placed proximal to the 23mm aortic extender components.The leak was reportedly sealed.It was reported that both of the patient's renal arteries were covered, and the aortic extender components were placed up to the patient's superior mesenteric artery.The patient reportedly received 5 units of blood in total.A dialysis catheter was placed in the patient.The procedure was completed.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10268353
• Report Number: 3007284313-2020-00172
• Device Sequence Number: 14190887
• Product Code: MIH
• UDI-Device Identifier: 00733132622382
• UDI-Public: 00733132622382
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: 12/17/2020
• Device Model Number: RLT231416
• Device Catalogue Number: RLT231416
• Device Lot Number: 17570043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR