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

Model Number 9750TFX26

Device Problem Nonstandard Device (1420)

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

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by our edwards lifesciences affiliate in switzerland, during device preparation for a transfemoral transcatheter aortic valve replacement (tavr) procedure with a 26 mm sapien 3 ultra valve, prior to the crimping process after opening the valve, it was observed inside the saline bowl that two of the valve leaflets were not opening and closing properly.A decision was made to prepare a new valve.The second valve was implanted successfully with no reports of patient harm.The first valve device was returned for evaluation.Evaluation of the returned device revealed there was a crease across the leaflet of the valve.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on investigation.The following sections of this report have been corrected/updated: h6 (component code, type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).The device was returned to edwards lifesciences for evaluation.Visual inspection of the returned valve revealed one of the leaflets was in the opened position while the remaining two leaflets were in the closed position.During testing with a probe, the opened leaflet was flexed to the closed position and then back to the opened position while the closed leaflets were flexed to the opened position and then back to the closed position.The returned valve was visually observed in solution and the reported appearance/behavior of the leaflets were observed.All three valve leaflets were able to open and close with oscillation.Further inspection of the returned valve revealed a crease across the leaflet of the valve.Functional testing of the returned valve was also performed.Testing showed the valve opened and closed properly under the nominal stimulated patient test condition.A device history record (dhr) review was performed, and it did not reveal any manufacturing nonconformance issues that would have contributed to the events.A lot history review was also performed and revealed no other events relating to the reported events.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported events.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the valve and delivery system usage.Per the ifu/training manuals, it notes that the appearance of thv leaflets during the rinsing process should not be used to judge the adequacy of thv coaptation.During the manufacturing process, each thv is individually inspected to confirm proper coaptation under physiological backpressure conditions prior to release.Based on the review of the ifu/training manuals, no deficiencies were identified.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 events for the valve allegedly having inadequate coaptation and crease on the valve leaflet were confirmed through evaluation of the returned device.A review of the dhr, lot history and manufacturing mitigations did not provide any indication that a manufacturing non-conformance contributed to the events.A review of the ifu/training materials revealed no deficiencies.An in-depth evaluation regarding the alleged inadequate coaptation has been documented in a technical summary written by edwards lifesciences.In the technical summary, devices returned for this type of event were evaluated over a two-year span.The technical summary states that the summary of test data has demonstrated that all the returned valves functioned properly: possessing adequate coaptation and demonstrating unrestricted motion.All available data from events with returned devices support the existing device training instructions that are provided and that the adequacy of thv leaflet coaptation and appearance should not be evaluated during thv preparation.In summary, no evidence of a product non-conformance or device malfunction were found in any of the valves returned for these events.In this case, available information suggests that procedural factors (failure to follow instructions and user perception) may have contributed to the event.During evaluation of the returned device, creases were observed on the valve leaflet.This is likely due to workmanship from the manufacturing.In this case, available information suggests that a manufacturing issue (workmanship) may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.A product risk assessment (pra) was initiated to investigate the cause and assess the risks associated with the crease on valve leaflet event.Furthermore, a corrective and preventive action (capa) was initiated to capture further investigation and corrective/preventive action activities associated with the crease on valve leaflet event.

• 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: 18193696
• MDR Text Key: 329009475
• Report Number: 2015691-2023-17701
• 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,User Facility
• 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

• Date FDA Received: 11/22/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• 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