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

Model Number 9750TFX26A

Device Problem Nonstandard Device (1420)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

As reported by an edwards lifesciences field clinical specialist, during preparation of the 26mm sapien 3 ultra valve, it was observed that 2 leaflets were "stuck together/pinwheeled".A second 26mm sapien 3 ultra valve was prepped and successfully implanted in the aortic annulus.The first valve was returned to edwards lifesciences, and during initial device evaluation, it was observed that one of the valve leaflets had a creased tab.

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 h.6 component codes, additional codes added to h.6 type of investigation, corrected h.6 investigation findings, corrected h.6 investigation conclusions.The sapien 3 ultra valve was returned to edwards lifesciences for evaluation.A visual inspection was performed, and the following was observed: a crease was observed at the tab of a valve leaflet.Functional testing was performed confirmed that the valve opened and closed properly under the nominal stimulated patient test condition.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this 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.In this case, a crease at the tab of the valve leaflet was confirmed during engineering evaluation.A manufacturing issue was identified during the device evaluation.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.A product risk assessment was initiated for further investigation and to assess the risk of the issue identified.

• 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: 17760777
• MDR Text Key: 323755900
• Report Number: 2015691-2023-15994
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)260222
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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