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

Model Number 2800

Device Problems Calcified (1077); Incomplete Coaptation (2507); Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 10/23/2014

Event Type  Injury  

Event Description

Edwards received information that this aortic bioprosthetic device was explanted after twelve (12) years, six (6) months due to prosthetic valve insufficiency.As reported, "the noncoronary cusp of the prosthetic valve was torn at the commissures and it was not collapsing with the other leaflet.There was significant calcification of this leaflet." this was excised and replaced with a 25mm pericardial bioprosthesis.The patient was returned to the intensive care unit in stable condition.

Manufacturer Narrative

Although there have been attempts to receive further information regarding the device, the explanted bioprosthesis was not returned to edwards for analysis.Without return of the device, edwards is unable to conclusively determine the root cause for this event, or confirm the clinical observation.In this case, the observed tear at the commissure was likely due to the clinically observed "significant calcification of the leaflet." many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.) and mechanical stress related to the valve's hemodynamic performance.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Trends are monitored on a (b)(4) basis and if action is required, appropriate investigation will be performed.

• 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: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4267209
• MDR Text Key: 21496441
• Report Number: 2015691-2014-02753
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2004
• Device Model Number: 2800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2014
• Date Device Manufactured: 07/06/2000
• 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