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

Model Number 3300TFX

Device Problems Calcified (1077); Degraded (1153); Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation due to covid-19 infection.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.The root cause of the event was likely due to patient conditions and operational context.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported that a patient with a 23mm 3300tfx aortic valve implanted for 4 years, 9 months underwent redo aortic valve replacement due to patient-prosthesis mismatch, calcification, moderate to severe nonrheumatic aortic stenosis, thickened and sclerosed leaflets.The patient presented with nyha class iii heart failure.A 25mm 11500a aortic valve was implanted in replacement.Post-operative tee revealed excellent valve function with no significant perivalvular leaks.Patient tolerated the procedure well.Postoperatively, the patient developed intermittent chb and was paced and underwent a placement of a permanent pacemaker.The patient was discharged home on pod # 5.

Manufacturer Narrative

Manufacturer narrative: updated sections d4-expiration date, h4, and h6 (type of investigation).The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.

Manufacturer Narrative

Updated section h6: component codes, type of investigation, investigation findings, and investigation conclusions.The event occurred due to procedural factors.

• Brand Name: CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11749800
• MDR Text Key: 252265001
• Report Number: 2015691-2021-02732
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2020
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 79