MAUDE Adverse Event Report: EDWARDS LIFESCIENCES 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 08/23/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by an edwards finland affiliate, during a transfemoral tavr procedure with a 29mm sapien 3 valve, the commander delivery system got stuck inside of the esheath and was not able to advance.The system was removed from the patient as a single unit.Upon removal of the devices, a 'laceration' in the esheath was observed, and the valve was damaged at the bottom of one cell stent strut (slightly kinked).An iliac dissection was also observed requiring a stent.A new commander delivery system and esheath were used, and the valve was implanted successfully.The patient was in good condition.Per report, the perceived root cause for the event was a combination of borderline vessel diameter and esheath design.Per pre-decontamination evaluation, the following was observed: the liner was torn 1.5 cm in length from the strain relief, and the liner torn at 1cm from strain relief.A liner strand was visible.A hole at liner torn location.

Manufacturer Narrative

Correction to d1, d4 (model number, serial number, expiration date is unknown), h4 - manufacturing date is unknown.The event(s) reported is / are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was returned to edwards lifesciences for evaluation, the device was visually examined for any abnormalities, and the following was observed: in the crimped state, the valve had two (2) struts bent outwards at the inflow side, and the valve frame was distorted at the outflow side.After deployment of the valve by engineering, the valve frame was canted, and the leaflets were wrinkled and dehydrated due to the storage condition (prolonged crimping) during the return handling process.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported event was confirmed by the returned device.The root causes identified in the technical summary were reviewed, and the following were identified as applicable to this event: tortuous patient anatomy can create sub optimal angles that can lead to non coaxial alignment between the delivery system with the crimped valve and sheath inner lumen during advancement, leading to resistance.Although 'no pathological tortuosity' was reported, it is possible some tortuosity was present in the access vessel as curvature and kink were noted on the returned sheath.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.Per provided information, there was 'mild' calcification in the patient's access vessel.Undersized vessels (e.G.Due to anatomical variation, pre existing stent or graft, scar tissue, or fibrosis) can create a restricted pathway or constrained condition resulting in challenging pathway during delivery system advancement leading to resistance.Per provided information, access vessel diameter was 5mm, which is less than the required 5.5mm mld for 14f esheath.Excessive device manipulation and or high push force can lead to the valve struts interacting with the sheath shaft and resulted the strut damage at the valve inflow side.Per evaluation of the returned device, there were two (2) bent struts outwards at the inflow side.Additionally, the valve frame appeared distorted on the outflow side, which may be caused by excessive manipulation and or high push force during withdrawal of the system.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

Manufacturer Narrative

Additional information added to d4 (serial number).

• 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: 17844451
• MDR Text Key: 324601594
• Report Number: 2015691-2023-16432
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

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
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 11/16/2023; 12/12/2023
• Supplement Dates FDA Received: 12/04/2023; 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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