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

Model Number 9750TFX23

Device Problem Material Deformation (2976)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 09/07/2023

Event Type  Injury  

Event Description

As reported by an edwards europe affiliate, during a transfemoral tavr procedure with a 23mm sapien 3 ultra valve, the commander delivery system and valve got stuck 5-6 cm after insertion through the esheath, and one of the valve struts was observed to be bent.It was decided to remove the delivery system and valve through the esheath.After the withdrawal, a tear in the esheath that was noted.A new 23mm sapien 3 ultra valve was prepped, inserted, and implanted successfully.Per report, the patient had a vascular problem related to vascular access.During vascular femoral closure, the artery was occluded as the anchor got stuck in the dissection, possibly caused by the esheath tear.The team used a balloon dilator to solve the issue, but the symptoms of lower limb ischemia persisted.Vascular intervention was performed.The patient final outcome was good and the patient was discharged.Per report, the perceived root cause of this event was probably due to a 'technical issue' with the inner layer of esheath.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

The device was returned to edwards lifesciences for evaluation.The returned device was visually examined for any abnormalities, and the following was observed: four struts bent outwards on the inflow side.One strut bent sideways at the outflow side.The valve frame was distorted and canted.The valve was deployed by engineering and one strut remains bent.Post procedural images were provided, and the following was observed: as reported, 'esheath was cut by physician for exploration what happened with valve.' the strain relief is cut off and the crimped valve is exposed through the torn sheath liner, with a valve strut bent outwards at the inflow side.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The instructions for use/training manuals were reviewed for guidance/instruction involving the devices.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint for frame damage was confirmed based on provided imagery and returned device.As reported, 'the commander ds with the valve got stuck 5 - 6cm after insertion through esheath.Moreover, one of the valve struts was bent while advancing.All the system was removed through esheath.' follow up information stated that the patient's access vessels were mildly tortuous and calcified.Per training manual, 'push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.' calcification can reduce the vessel diameter and may increase restriction leading to resistance.Calcification and tortuosity can result in the creation of sub optimal angles during delivery system insertion that may lead to resistance.Excessive device manipulation and/or high push and pull force can lead to the valve struts interacting with the sheath shaft and resulted the strut damage at the valve outflow side.Based on available information, investigation suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation) may have contributed to the reported event.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: 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: 18068891
• MDR Text Key: 327353135
• Report Number: 2015691-2023-17273
• 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: 12/07/2023

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: 9750TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention