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); Appropriate Term/Code Not Available (3191)

Patient Problem Aortic Regurgitation (1716)

Event Date 03/09/2015

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.In this case, edwards received information that this device was explanted after eleven (11) years, five (5) months due to aortic insufficiency, secondary to degeneration.Upon clinical observation, one leaflet had torn from its post and was prolapsing into the outflow tract of the left ventricle.The leaflets were somewhat thickened but there was no significant calcification.This was excised and replaced with a 21mm pericardial bioprosthetic with no complications.The patient was transferred from the or to the icu in stable but critical condition and is noted to be "discharged home and doing well.".

Manufacturer Narrative

Leaflet prolapse.Thickened leaflet.Method: device not returned: additional manufacturer narrative: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.The explanted device was not returned to edwards for analysis.Without return of the device, edwards is unable to confirm the clinical observation.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.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: 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: 4746781
• MDR Text Key: 17217208
• Report Number: 2015691-2015-01021
• 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: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2007
• Device Model Number: 2800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Date Device Manufactured: 08/08/2003
• 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: 71 YR