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

Model Number 2800

Device Problems Degraded (1153); Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Leaflet tears 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 explanted device was not returned to edwards for analysis because it was discarded at the hospital.Without return of the device, edwards is unable to conclusively determine the root cause for this event, or confirm the clinical observation.However, advances in valve design and bioprosthetic material have been made with the intention of reducing regurgitation by providing more efficient hemodynamics and longer tissue durability.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that this bioprosthetic aortic heart valve was explanted after fifteen (15) years, two (2) months due to aortic valve insufficiency, secondary to degeneration.Upon visualization, the valve showed significant structural valve deterioration in the right and non-coronary cusps with tears at the commissural post between the right, left, and non.This was replaced with a 27mm pericardial bioprosthesis and inspection revealed good seating and no paravalvular leak.The patient was later discharged on pod #5.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT RSR 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: 5877198
• MDR Text Key: 52162893
• Report Number: 2015691-2016-02514
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• 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: 76 YR