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

Model Number 2800

Device Problem Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 05/05/2015

Event Type  Injury  

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.Edwards received information that a 23mm bioprosthetic aortic valve, implanted for approximately seventeen (17) years, and five (5) months, was explanted due to torn leaflets causing aortic insufficiency.Pathology report indicated that there was a small amount of attached gray-white tissue overgrowth on the sewing ring of the valve.

Manufacturer Narrative

Method: device not returned.Additional manufacturer narrative: the device was not returned to edwards for analysis as it was discarded by the hospital.A review of the design history record confirmed that this device passed all manufacturing and sterilization inspections.There are many factors that could result in the report of a failing bioprosthetic valve, the most common of which is regurgitation.These complications can have many root causes, including but not limited to patient factors, (age, disease states, comorbidities), pharmacological factors, or procedure factors.In this case, it was reported that the torn leaflets caused the regurgitation.Without the return of the device, the clinical statements cannot be confirmed and the root cause for torn leaflet of this device remains indeterminable.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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4913593
• MDR Text Key: 6029073
• Report Number: 2015691-2015-01682
• 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: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2001
• Device Model Number: 2800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2015
• Date Device Manufactured: 10/31/1997
• 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: 84 YR
• Patient Weight: 92