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

Model Number 300021MM

Device Problem Torn Material (3024)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: x-ray demonstrated heavy calcification on leaflets 1 and 2, minimal calcification on leaflet 3, and wireform intact.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3mm on leaflet 3 at the inflow aspect and 4mm on leaflet 3 at the outflow aspect.Leaflet 1 had a 9mm tear near commissure 1.Leaflet 1 also had a tear at the free margin of 4mm; 3mm tore through the leaflet and 1mm was non-transmural at the inflow aspect.Leaflet 2 had a 10mm tear near commissure 2, of which approximately 5mmx2mm was missing and was not returned.Leaflet 2 also had a 5mm tear near commissure 3; 3mm tore through the leaflet, and 2mm was non-transmural at outflow aspect.Calcification was evident near the tears.Leaflets appeared thickened and swollen.Additional manufacturer narrative: based on the product evaluation findings, the clinical observation was confirmed.Regurgitation was visually confirmed due to leaflet tears.The observation of calcification, thickened tissue and host tissue restricted leaflet mobility which led to stenosis.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.Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.There can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd), a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Central regurgitation can also develop progressively if host fibrotic tissue grows onto the bioprosthetic valve.The growth may interfere with functionality of the device as the leaflet motion may be restricted leading to abnormal coaptation.Calcific degeneration is contributed to many factors which include patient factors (age, disease state, pharmacological intervention, etc.) mechanical stress related to the valve¿s hemodynamics performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edward¿s tissue valves due to anti-calcification treatments during manufacturing.A definitive root cause could not be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that a 211 mm pericardial aortic valve was explanted due aortic stenosis and regurgitation secondary to dropped leaflet caused by leaflet tear after an implant duration of eight years and 2 months.One of the leaflets was dropped due to leaflet tear.The valve was explanted and replaced with a 19 mm non-edwards valve with no adverse patient effects reported as a result of the valve replacement.The patient status was reported as ¿recovered¿ at icu.Multiple cardiac surgery procedure: cabg at implant.

• Brand Name: CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irivne CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms t&d2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6012728
• MDR Text Key: 56910369
• Report Number: 2015691-2016-02980
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Health Professional
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Model Number: 300021MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2008
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75