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

Model Number 9750TFX23A

Device Problem Material Deformation (2976)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 23 mm sapien 3 ultra valve in the aortic position via transfemoral approach, valve bent strut was noted exiting the sheath.The system was removed from the patient.A new system was prepared and successfully used.The valve was successfully deployed.There was no suspected esheath damage.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was provided from the site and revealed the following: no notable calcification in the access vessels.Vessel diameters sufficient for 23mm thv and 14f esheath+ (greater or equal 5.5mm).Tortuosity present in the access vessels.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was unable to be confirmed due to unavailability of returned device/relevant imagery.A review of the dhr did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.As reported, ''during the procedure of a 23 mm sapien 3 ultra valve in the aortic position via transfemoral approach, valve bent strut was noted exiting the sheath''.Per training manual, ''push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification''.Per review of provided 3mensio report, no notable calcification was observed in the access vessels and the vessel diameters were sufficient for 23mm thv and 14f esheath+ (greater or equal 5.5mm).Tortuosity was observed in the access vessels.Tortuosity 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, which can cause the valve struts to get caught on the sheath and become damaged.As such, available information suggests that patient factors (tortuosity) 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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• 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: 19094113
• MDR Text Key: 340569089
• Report Number: 2015691-2024-02801
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)270116
• 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: 05/28/2024

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: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2024
• 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