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 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.H3 other text : not returned.

Event Description

During a tavr procedure using a 26mm sapien 3 resilia valve via transfemoral approach, the implanter left a portion of the unexpandable part of the sheath outside the body, when trying to advance the valve through the sheath, and resistance was met.A check under fluoro indicated a bent strut with a small puncture hole in the strain relief.The decision was made to remove everything and start over with a new sheath, valve, and delivery system.The new sheath was inserted all the way to the skin after discussing the importance of the unexpandable portion of the sheath with the implanter.There was no injury to the patient.

Manufacturer Narrative

The 26mm sapien 3 ultra resilia valve was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Imagery was provided that showed the patient's vessels had the presence of calcification and tortuosity.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.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 reported event of frame damage was unable to be confirmed as no device/relevant imagery was returned.An existing technical summary captures the root cause analysis for complaints evaluated for resistance with delivery system and valve frame damage as a result of increased push force.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.Per imaging evaluation, the patient's access vessels had the presence of tortuosity.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 imaging evaluation, the patient's access vessels had presence of calcification.Excessive device manipulation/high push force can lead to the valve struts interacting with the sheath shaft and resulted in the strut damage at the valve inflow side.As reported, "when trying to advance the valve through the sheath, resistance was met.A check under fluoro indicated a bent strut." 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 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 non-conformance 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 that it is unlikely that a manufacturing non-conformance contributed to the 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.In this case, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive 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.The complaints for difficulty advancing the commander delivery system with crimped valve through the esheath resulting in a high push force and frame damage has been previously identified in product risk assessment (pra).

• 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: 18025918
• MDR Text Key: 326821166
• Report Number: 2015691-2023-17133
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)260320(11)2303212110411466
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

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: 10/04/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 12/02/2023
• Supplement Dates FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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 Sex: Male