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

Model Number 3300TFXJ19

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

Patient Problem Aortic Valve Stenosis (1717)

Event Date 07/23/2019

Event Type  Injury  

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.In this case, the patient required intervention to treat the patient prosthesis mismatch.Based on the available information, the root cause for the ppm and stenosis remains indeterminable.However, it is likely that patient related factors and procedural factors at initial implant contributed to the event.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that this 19mm aortic pericardial valve, implanted for unknown period, was explanted due to aortic stenosis secondary to prosthesis-patient mismatch.This device was originally implanted at a different hospital.After that, since aortic pressure gradient was increased due to prosthesis-patient mismatch, re-operation was performed to correct pressure gradient.This device was explanted and replaced with a 23mm edwards pericardial aortic valve with no adverse patient effects reported as a result of the valve replacement.The patient status was reported as ¿under treatment¿.The device was not returned for evaluation as it was discarded at the hospital.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8913320
• MDR Text Key: 156308825
• Report Number: 2015691-2019-03096
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3300TFXJ19
• 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; Required Intervention