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

Model Number 280025MM

Device Problems Degraded (1153); Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 06/24/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.The clinical observation was unable to be confirmed.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.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.In this case, svd was most likely due to a patient condition/factors.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 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 it was reported via the implant patient registry that a 25mm bioprosthetic valve was treated with an edwards valve-in-valve intervention after an implant duration of sixteen (16) years, four (4) months due to aortic regurgitation with severe prolapse that is likely degenerative (torn).Tee revealed mild aortic valve periprosthetic regurgitation with residual regurgitation through the previously placed plug.The patient tolerated the procedure well and was transferred out of the cath lab in stable condition.

• Brand Name: CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms t&d2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5835278
• MDR Text Key: 50909632
• Report Number: 2015691-2016-02379
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 280025MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2016
• 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: 88 YR