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 10/17/2023

Event Type  malfunction  

Event Description

As reported from italy by our edwards lifesciences affiliate, during a transfemoral transcatheter aortic valve replacement procedure with a 26 mm sapien 3 ultra valve, resistance was felt while pushing the valve and delivery system through the esheath.The valve became stuck in the esheath, and the sheath was cut by the valve.The valve frame was noted to be bent.The devices were removed and exchanged.The new valve was deployed successfully.No vascular damage was found at iliac and femoral angiography, and the patient outcome was good.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on the device evaluation.The following sections of this report have been updated: corrected d9, corrected h3, corrected h6 component codes, additional codes added to h6 type of investigation, corrected h6 investigation findings, corrected h6 investigation conclusions.The sapien 3 ultra 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.Imagery was provided by the site and revealed the following: one (1) strut appeared bent outward at inflow side, and the valve appeared exposed through sheath.There are 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 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 complaint event.The instructions for use/training manuals were reviewed for guidance/instruction involving the sapien 3 ultra 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 provided imagery.An existing technical summary written by edwards lifesciences captures the root cause analysis for complaints 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.Tortuosity was noted during preprocedural planning.- 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.Calcification was noted during pre-procedural planning.- 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 reported resistance was felt while pushing the valve through esheath.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 resulted in frame damage.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (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 escalation is required at this time.H3 other text : despite multiple attempts to obtain the device, the device was not returned to the manufacturer.

• 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: 18095338
• MDR Text Key: 327668261
• Report Number: 2015691-2023-17328
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

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: 9750TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2023
• 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: 83 YR