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

Model Number 9750TFX23A

Device Problems Nonstandard Device (1420); Incomplete Coaptation (2507)

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

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

During device prep for a tavr procedure using a 23mm sapien 3 ultra valve, the implanter asked for the valve to not be implanted due to leaflets not coapting after visual inspection.Another valve was used and implanted successfully.The valve was returned for examination and the preliminary findings found a crease at the tab and a crease across the leaflet.

Manufacturer Narrative

Correction to h6; type of investigation, investigation findings, investigation conclusion.The 23mm sapien 3 ultra valve was returned for examination.A visual examination found that upon opening the jar, leaflets cp1 and cp2 were in an opened position, cp3 leaflet was in a closed position.Creases were observed due to one leaflet at the free edge bent outward and mismatched.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the complaint code.The following instructions for use (ifu) were reviewed: commander delivery system with s3/s3u/s3ur.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 this review, no ifu/training 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 complaints for device preparation-valve/component anomaly-alleged inadequate coaptation and device preparation-valve/component anomaly-other were confirmed based on the returned device.In the technical summary, devices returned for these complaints over a two-year span were evaluated.The technical summary states that the summary of hydro-performance test data has demonstrated that all the returned complaint valves functioned properly: possessing adequate coaptation and demonstrating unrestricted motion.All available data from complaints with returned devices support the existing device training instructions, provided to the clinical specialist and physician, that the adequacy of thv leaflet coaptation and appearance should not be evaluated during thv preparation.Additionally, the technical summary demonstrates that the manufacturing mitigations in place support that is unlikely a manufacturing non-conformance would contribute to the complaints.It should be noted that these mitigations (from manufacturing and the ifu/training manual) as identified in the technical summary are still in place.In summary, no evidence of a product non-conformance or device malfunction were found in any of the valves returned for these complaints.Per device evaluation, crease was observed on the leaflet, which was potentially caused by leaflet bent outward and mismatch due to workmanship from the manufacturing.Available information suggests that manufacturing issue (workmanship) may have contributed to the complaint event.A product risk assessment and capa was initiated for further investigation and assess the risk of the nonconformance identified.In this case, available information suggests that procedural factors (failure to follow instructions/user perception) may have contributed to the complaint 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.

• 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: 17949899
• MDR Text Key: 325919892
• Report Number: 2015691-2023-16859
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)260320
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• 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: Female