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

Model Number 3000TFX

Device Problems Degraded (1153); Torn Material (3024); Appropriate Term/Code Not Available (3191)

Patient Problem Aortic Regurgitation (1716)

Event Date 08/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation summary: the explanted device was returned to edwards for analysis.As received, minimal host tissue overgrowth encroached onto the tissue and into the orifice on leaflet 3 at the inflow aspect.The x-ray demonstrated moderate calcification on leaflet 1 and 2, one calcification nodule on leaflet 3, and an intact wireform.Leaflets were thickened and swollen along the commissures.Leaflet 1 had a non-transmural tear near commissure 2.Leaflet 2 had a tear along commissure 2, and a non-transmural tear along commissure 3.Leaflet 3 had a non-transmural tear along commissure 3.Thickened tissue was observed near the tears.(b)(4).Leaflet tears and leaflet disruptions occurring over time are a form of structural valve deterioration that may ultimately result in significant regurgitation requiring replacement of the valve.In this case, the clinical report of a torn leaflets were confirmed through visual observations of the returned device.Calcification plays a major role in the failure of bioprosthetic heart valves and can result in tearing or stenosis of the prosthesis.Many factors contribute to the onset and propagation of calcification including patient factors (age, disease state, pharmacological intervention, etc.) and mechanical stress related to the valve's hemodynamic performance.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.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 25mm bioprosthetic aortic heart valve was explanted after nine (9) years, seven (7) months due to severe aortic valve regurgitation, secondary to a torn leaflet.Upon visualization, the valve was noted to be severely degenerated with thickened valve leaflets.There was also severe dehiscence of approximately 50% of the valve ring away from the root.An aortic root replacement was performed and the valve was replaced.There were no reported complications and the patient was later discharged on post-operative day #5.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms: t&d 2nd floor, office t223; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5954152
• MDR Text Key: 54878705
• Report Number: 2015691-2016-02758
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2008
• Device Model Number: 3000TFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR