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

Model Number 9600TFX29

Device Problem Incomplete Coaptation (2507)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards european affiliate, the patient underwent implant of a 29mm sapien 3 valve within the mitral position inside a pre-existing ring.After successful implantation, it seemed that one leaflet did not work in echo controlling.A second s3 29mm valve was implanted.Patient outcome was successful.

Manufacturer Narrative

Corrected h.6 investigation conclusion codes.The device was not received for evaluation.Imagery was provided, but it was not relating to the complaint event.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to these complaint events.During manufacturing of the sapien 3 transcatheter heart valve, the valve and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The instructions for use (ifu), device preparation training manual, and procedural training manual were reviewed for instructions or guidance for proper preparation and use of the devices.Post-deployment thv assessment, the physician is instructed to assess the thv post-deployment using fluoroscopy.Withdraw the delivery system from the valve before assessing.Perform post angiogram with wire still in lv to assess, thv position and complete expansion, patency of coronary arteries, functional assessment of valve (ar, pvl, etc.), and annular and aortic integrity.A stiff wire tends to exacerbate central ar.Assess the thv post-deployment using tee in multiple places, the long axis (check for severity of ar and thv position relative to coronary arteries) and short axis (check central versus paravalvular regurgitation.No ifu/training deficiencies were identified.A complaint history review on confirmed device complaints from march 2020 through february 2021 for the sapien 3 valve was performed with the codes identified.Prior closed complaints with any of the codes were reviewed for similar events and root cause identified.None of the root causes are potentially applicable to this complaint event.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.Since no product non-conformances or ifu/training deficiencies were identified during the evaluation, a product risk assessment escalation is not required.Additionally, since no manufacturing non-conformances or ifu deficiencies were identified, corrective action is not required.The event was unable to be confirmed as relevant images were not provided for evaluation.A review of dhr, lot history, complaint history, and manufacturing mitigation's did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of the ifu and training manual revealed no deficiencies.During the manufacturing process, all sapien 3 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 event.As reported, 'after successful implantation, it seemed that one leaflet did not work in echo controlling'.There are several potential patient and procedural factors that alone or in combination can cause or contribute to a report of motion restricted leaflet.Potential factors include too ventricular/atrial deployment of the valve in combination with native leaflet overhang, leaflet impingement in a highly calcified native valve, impingement of a leaflet due to the guide wire, or slow recovery of adequate ventricular flow post valve deployment and rapid pacing.These factors could impact and hinder proper leaflet functionality.For this case, a definitive root cause is unable to be determined at this time due to the insufficient information.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11350940
• MDR Text Key: 232841523
• Report Number: 2015691-2021-01343
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2022
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention