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

Model Number 9750TFX26

Device Problem Material Deformation (2976)

Patient Problem Vascular Dissection (3160)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device was not returned.

Event Description

As reported, it was a case of a 26mm sapien 3 ultra valve, in aortic position by transaxilary approach.During procedure, resistance was felt when the delivery system into the esheath and a bent valve strut was observed on x-ray.The esheath started to open and the strut of the valve was protruding from the esheath.The valve had not been advanced out of the esheath and the system was removed as a single unit.A new kit was prepared and the valve was successfully deployed.Upon closing the puncture site there was bleeding from the axillary artery, therefore, 2 vascular stents were placed.The patient final outcome was good.

Manufacturer Narrative

The device was returned to edwards lifesciences for evaluation and the following was observed.One (1) strut bent outward at the inflow side and leaflets wrinkled and dehydrated due to storage condition (prolonged crimping) during the return handling process.Imagery was provided from the site and revealed the following: bent strut appear to protrude through the esheath and presence of tortuosity in patient's access vessel.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was confirmed based on the evaluation of the returned device and provided picture.Available information suggests that patient factors (calcification, tortuosity) and procedural factors (high push force likely contributed to the event as tortuosity was present in patient's access vessel.Additionally, per follow-up with field clinical specialist (fcs), the degree of tortuosity and calcification in patient's access vessel was moderate.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Scratches observed on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.Tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.Excessive device manipulation or high push force can lead to the valve struts interacting with the sheath shaft and result in the strut damage at the valve inflow side.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18127496
• MDR Text Key: 327995685
• Report Number: 2015691-2023-17474
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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: 9750TFX26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male