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

Model Number 2700

Device Problems Calcified (1077); Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 04/20/2015

Event Type  Injury  

Event Description

Edwards received information that this aortic valve was explanted after approx.Eleven (11) years, three (3) months due to insufficiency secondary to calcification.As reported, the leaflets had moderate to severe calcification and also exhibited a tear.This was replaced with a 23mm pericardial bioprosthesis.The patient remained stable and was returned to the surgical intensive care unit.

Event Description

Edwards received additional information indicating the implant duration of this device was twelve (12) years, three (3) months.

Manufacturer Narrative

Evaluation summary: the explanted device was returned to edwards for analysis.As received, the valve's suture ring was cut into pieces, exposing the wireform around a leaflet.The x-ray demonstrated heavy calcification in the cusp area of all three (3) leaflets.One (1) leaflet was torn along the commissure and on the cusp area along the wireform.Another leaflet was torn at the free margin and into the cusp area.Tissue swelling was observed on the free margin of all leaflets and there was a gap in the central coaptation region.Heavy host tissue overgrowth encroached onto the tissue and into the orifice and on a leaflet at the outflow and inflow aspect.Host tissue was minimal around the stent circumference at the outflow and inflow aspect.Hematoma was observed on two (2) leaflets on the outflow aspect.Method: #86 = x-ray.The clinical observation of calcification could be confirmed as calcification restricted mobility in the leaflets and led to stenosis.Calcification plays a major role in the failure of bioprosthetic heart valves and many factors contribute to its onset and propagation.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.Edwards will continue to review and monitor all events.If further information becomes available, a follow-up report will be submitted.

Manufacturer Narrative

Additional manufacturer narrative: 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.Reference mfr # 2015691-2015-01163.Describe event of problem : edwards received additional information indicating the implant duration of this device was twelve (12) years, three (3) months.Implant date : (b)(6) 2003.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT AORTIC 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: 4782962
• MDR Text Key: 5798226
• Report Number: 2015691-2015-01161
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2006
• Device Model Number: 2700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2002
• 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: 73 YR