MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SAPIEN 3 ULTRA SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26

Device Problems Failure to Advance (2524); Material Deformation (2976); Material Protrusion/Extrusion (2979)

Patient Problem Perforation (2001)

Event Date 02/15/2022

Event Type  Injury  

Event Description

Elderly male with history of severe aortic stenosis.Procedure: transcatheter aortic valve replacement (tavr) with an edwards 26 mm s3 valve via left axillary artery access.During tavr, via the left subclavian, edwards 14 fr sheath was "kinked" in the patient which caused the valve to not be able to go down the sheath.The valve then tore the sheath and had a point sticking out of the sheath casing which caused the perforation in the axillary artery.The system was removed, and a new system inserted with success.A 6x29n mm vbx covered stent repaired/sealed the perforated artery.Outcome: additional surgery- repair graft.Overnight stay.Patient discharged next day.Patient had poor access from the groins and therefore a left axillary artery approach was planned.2nd procedure: a small access was taken from the right groin.Right ventricular pacing wire was placed and tested.A pigtail was placed in the aortic root and the proper coplanar angle determined.Main access was taken through the left axillary artery.A straight wire was placed across the aortic valve into the left ventricle and then exchanged for a safari wire.When all was in readiness, the delivery system was placed on the wire and passed into the axillary artery.In one position, it was very difficult to advance and therefore it was removed and examined.It did appear that a strut of the valve had torn through the sheath and a small part of it was protruding.It was felt that the axillary artery may have sustained an injury from this.Therefore, an entirely new delivery system was used for the new valve.This was passed through the axillary artery without incident and then across the valve.It was deployed during a period of rapid pacing.It deployed well and had low gradients and no paravalvular leak.This was felt to be satisfactory.D/c summary: echocardiogram done this morning reviewed by doctor and shows normally functioning bioprosthetic valve with no significant pericardial effusion.He is stable for discharge home at this time.Will place patient on 1 week course of antibiotics due to wound on back.Discharge instructions, restrictions, wound care, and medication changes discussed with the patient at length and all questions were answered.He will be seen back in the structural heart clinic in approximately 30 days with echocardiogram prior to office visit.Manufacturer response for introducer, catheter, edwards esheath introducer set (per site reporter): will investigate.Manufacturer response for prosthesis, aortic valve, percutaneously delivered, edwards sapien 3 ultra transcatheter heart valve (per site reporter): will investigate.Manufacturer response for prosthesis, aortic valve, percutaneously delivered, sapien 3 ultra system (per site reporter): will investigate.

• Brand Name: SAPIEN 3 ULTRA SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 13677693
• MDR Text Key: 286644297
• Report Number: 13677693
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)230526(10)63804344
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 63804344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 26280 DA
• Patient Sex: Male
• Patient Weight: 85 KG