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

Model Number 9755RSL26A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.H3 other text : device remains implanted.

Event Description

As reported by an edwards lifesciences field clinical specialist, during a right-side transfemoral transcatheter aortic valve replacement procedure, there was minor difficulty inserting the commander delivery system and sapien 3 ultra resilia through the 14fr esheath+.As gross valve alignment was being performed, two bent struts at the inflow were observed on the valve frame.The valve was deployed without issue, however, the struts remained bent even after expansion.The devices were withdrawn without issue and the patient did not experience any injury.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on the device evaluation.The sapien 3 ultra resilia valve was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Procedural imagery was provided and showed multiple bent valve struts at the inflow side.Additional imagery provided revealed the patient's right access vessel had the presence of calcification and tortuosity.Edwards lifesciences has extensive manufacturing mitigations in place to detect a defect or nonconformance associated with valve frame damage.There are several 100% in-process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.These inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the event.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance that would have contributed to this event.The instructions for use/training manuals were reviewed for guidance/instruction involving the valve usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of the risk management documentation was performed, and 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 valve frame damage was confirmed through review of the provided imagery.An existing technical summary by edwards lifesciences captures the root cause analysis for events evaluated for resistance with delivery system and valve frame damage as a result from increased push force.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 crimped valve and sheath inner lumen during advancement, leading to resistance.As per imagery, tortuosity was present in the patient's right 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.As per the imagery received, calcification was present in the patient's right access vessel.Excessive device manipulation/ high push force can lead to the valve struts interacting with the sheath shaft and resulted the strut damage at the valve inflow side.As per the imagery received, multiple struts were bent at the inflow side.The presence of the above factors can create 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.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation, high push force) 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.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 RESILIA 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: 17817927
• MDR Text Key: 324263724
• Report Number: 2015691-2023-16174
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)260308(11)2303092110332923
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

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 Model Number: 9755RSL26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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 Age: 89 YR
• Patient Sex: Male