MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9755RSL23A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/10/2024

Event Type  Injury  

Event Description

As reported by the edwards field clinical specialist, post valve deployment of a sapien 3 ultra resilia valve in the aortic position, mild to moderate central leak was noted.A 2nd sapien 3 ultra resilia valve was implanted and the central resolved.There was no harm to the patient.The perceived root cause was due to annular calcium, a couple of large deposits of calcium.

Manufacturer Narrative

The investigation is ongoing.H3 other text : the valve remains implanted in the patient.

Manufacturer Narrative

A supplemental report is being submitted with an update with correct serial number.The following sections of this report have been updated: d4: serial number, expiration date, and unique identifier (udi) number and h4: device manufacture date.

Manufacturer Narrative

Update to h2 (type of investigation, investigation findings and investigation conclusions) h6 and h10 to reflect engineering evaluation.The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaint for deployed valve exhibits central regurgitation is unable to be confirmed due to no imagery, medical report, nor device provided.A review of the dhr did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu/training materials revealed no deficiencies.During the manufacturing process, all sapien 3 ultra resilia valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the complaint event.In this case, significant calcium deposits were reported within the patient's annulus.Although transcatheter heart valve depends on native landing zone calcification for anchoring, bulky calcification within the landing zone may impact the ability for the thv leaflets to properly function.The bulky calcium can impinge on the thv leaflets, preventing them from proper coaptation and lead to regurgitation.In this case, the valve exhibits central regurgitation after valve deployment was unable to be confirmed.The available information suggests that patient factors (calcification) likely contributed to the complaint 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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, 23MM
• 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: 18608359
• MDR Text Key: 334112062
• Report Number: 2015691-2024-00659
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9755RSL23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Male