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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

During a tavr procedure using a 26mm sapien 3 ultra valve via transfemoral approach, during insertion of the valve trough the esheath resistance was noted with the loader was fully inserted.The valve was check under angiography and the valve frame was kinked.A decision was made to remove the system and open a new kit.The implant was successful, and the patient was doing well post-procedure.As per medical opinion, a calcification kinked the frame of the valve.Patient demographics were unable to be obtained at this time.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-10698.

Manufacturer Narrative

Update to section a.Patient demographics was received.

Manufacturer Narrative

Correction to h6; type of investigation, investigation findings, investigation conclusion.Update to d9 and h3.The returned 26mm sapien 3 ultra valve was visually inspected, and the following was observed: the crimped valve showed one bent strut at the inflow side and the sheath shaft had curvature.Once the valve was post expanded there was one strut that remained bent after expansion.The frame was slightly canted, and the leaflets were wrinkled and dehydrated due to storage conditions.Functional testing and dimensional analysis were unable to be completed.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 through the returned product evaluation and provided imagery.An existing technical summary captures the root cause analysis for complaints evaluated for resistance with the delivery system and valve frame damage as a result of increased push force.The product risk assessment is also captured in technical which applies to this complaint event.The pra documents the difficulty advancing the delivery system through the sheath, resulting in difficulty or the inability to introduce the delivery system/loader and advance through the sheath, prolonging the procedure, which did occur during this event.The root causes identified in 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 crimped valve and sheath inner lumen during advancement, leading to resistance.The returned sheath shaft has curvature indicating a tortuous access vessel.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Similar to tortuosity, calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Per follow-up communication, it was reported, "as per medical opinion, a calcification kinked the frame of the valve even if the diameter of the vessel was good." a steep insertion angle can result in non-coaxial alignment between the delivery system and sheath.Non-coaxial advancement of the delivery system through the sheath may lead to resistance.Per follow-up communication, it was reported the sheath was inserted at a steep angle.Excessive device manipulation/high push force can lead to the valve struts interacting with the sheath shaft and resulting in strut damage at the valve inflow side.As reported, "during insertion of the valve through the esheath an important resistance was noted".The presence of the above factors can create a challenging pathway during delivery system advancement, leading to resistance.More than one of these factors can compound to further exacerbate the patient/procedural conditions and increase the likelihood of encountering resistance during delivery system advancement through the sheath resulting in frame damage.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with this issue.There are several 100% in-process inspections (visual) performed in the manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.These inspections and testing support the fact that is is unlikely that a manufacturing non-conformance contributed to this complaint.In addition, an assessment of the detailed instructions for use (ifu), device preparation training manuals, and procedural use training manual revealed no identifiable deficiencies.These mitigations (from manufacturing and the ifu/training manual) as identified in the technical summary are still in place to mitigate this issue.Based on available information, investigation suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation, high push force, steep insertion angles) 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.The complaint for difficulty advancing the commander delivery system with s3u/s3ur crimped valve through the esheath resulting in a high push force has been previously identified in product risk assessment (pra).

• 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: 16335687
• MDR Text Key: 309167692
• Report Number: 2015691-2023-10696
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2024
• Device Model Number: 9750TFX26
• Device Catalogue Number: 9750TFX26A
• 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: 02/09/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 02/09/2023; 03/01/2023; 04/25/2023
• Supplement Dates FDA Received: 02/09/2023; 03/06/2023; 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 70 KG