MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS; HEART-VALVE, REPLACEMENT

Model Number 3300TFX

Device Problems Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583); Difficult to Open or Close (2921); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Valve Stenosis (1717); Congestive Heart Failure (1783)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.Ppm has been shown to be associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival.High gradient can be a result of possible valve related and/or non-valve related issues.Higher than expected gradient may require surgical/percutaneous intervention.Also, there can be several root causes of leaflet immobility or leaflet restriction; where the leaflet or leaflets are not functioning as intended leading to regurgitation.Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, the nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The root cause of this event cannot be determined with the available information.However, this event was most likely impacted by patient and/or procedural related factors.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a patient with a 21mm 3300tfx magna ease aortic valve went in valve-in - valve procedure after an implant duration of six(6) years eight (8) months due to aortic stenosis.A successful tavr was performed with a 23mm 9750tfx sapien 3 ultra transcatheter valve.The patient was taken to the recovery room in stable condition.The patient was discharged on pod# 3.

Manufacturer Narrative

H10:  additional manufacturer narrative: added additional conclusion coding to section h6.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10322347
• MDR Text Key: 200654336
• Report Number: 2015691-2020-12692
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2017
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR