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

Model Number 9750TFX26

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

Per report received from ireland, it was a case of an implant of a 29mm sapien 3 valve, in aortic position by transfemoral approach.A lot of resistance was noticed during advancement of the commander delivery system through the esheath.Then, it was detected a strut in a strange angle of the valve through the esheath by fluoro.When the devices were removed, the valve was protruding through the esheath.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The complaint for "general risk - failure - frame damage" was unable to be confirmed.An existing technical summary 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.As per follow up patient had mild tortuous anatomy -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 follow up patient had mild presence of calcium at 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 reported "a lot of resistance was noticed during advancing commander ds through esheath and got stuck inside.Then, it was detected a strut in a strange angle trough esheath by fluoro." 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 resulted 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 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, 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.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA
• 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: 17775990
• MDR Text Key: 323759262
• Report Number: 2015691-2023-16038
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• 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