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

Model Number 3000

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Thrombosis (2100)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as patient has (b)(6).The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Based on the information received the cause cannot be conclusively determined; however, patient factors likely contributed to the event.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 a 21mm aortic valve was explanted after an implant duration of eleven (11) years, twenty-nine (29) days, due to stenosis, regurgitation, and pannus.The noncoronary leaflet on the prosthetic valve appeared to be thrombosed and had some thickening, as well as appeared to be torn.The explanted device was replaced with a 23mm aortic valve.The patient tolerated the procedure well and was transported to the surgical intensive care unit in stable condition.

• Brand Name: CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms t&d 2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5790805
• MDR Text Key: 49429600
• Report Number: 2015691-2016-02222
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S018
• 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: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2009
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2016
• Date Device Manufactured: 05/11/2005
• 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: 70 YR
• Patient Weight: 102