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

Model Number 3300TFX

Device Problems Fluid/Blood Leak (1250); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.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.It is likely that patient related factors contributed to the event.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a patient with a 23mm valve implanted in pulmonic position for five years, two months underwent a valve-in-valve procedure due to patient prosthesis mismatch and moderate to severe pulmonic regurgitation.Patient had chronic diastolic heart failure.A 26mm valve was implanted.Pod 1 tte showed appropriately functioning valve.The patient was discharged home on pod #2.

Manufacturer Narrative

Additional 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.Corrected data: updated h6 (findings, conclusions).The root cause of the event was procedural factors.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESES
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11704987
• MDR Text Key: 248352965
• Report Number: 2015691-2021-02593
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057S042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/28/2019
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 33 YR