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

Model Number 3300TFX

Device Problems Folded (2630); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716); Thrombosis (2100); No Information (3190)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information are in process.Bioprosthetic valves have been proven to have excellent long term durability.Replacement of a bioprosthetic valve over time is more likely due to structural valve deterioration (svd) which occurs as a result of stenosis (from calcification or host tissue overgrowth), dehiscence, fibrosis or non-calcific degeneration or endocarditis.These are typically due to patient factors such as age, gender, and prior medical history of hypertension, diabetes and renal disease.Without additional information or return of the device the clinical observation cannot be confirmed and cause remains indeterminable.If additional information is received a supplemental mdr will be submitted.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 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 learned a 25 mm aortic valve implanted 11 months was explanted and replaced with the same model and size device due to unknown reasons.No complications were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Additional manufacturer narrative: host tissue/pannus growth is a complex process triggered by the interaction between the host and the device and is highly variable among patients.Literature defines pannus as a type of scarring and tissue ingrowth.It is not currently possible to predict the occurrence and severity for any given patient with a bioprosthetic heart valve.A certain degree of host tissue growth is expected.However, abnormal or severe pannus growth can eventually affect the function of the valve.Valve thrombosis is a rare and well-recognized complication of prosthetic valves.Valve thrombosis is the formation of significant blood clots forming on the valve.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Immediate intervention, either by thrombolytic therapy or valve replacement is required for significant thrombosis.Alternatively, there may be cases where the patient is placed on an anticoagulant to treat thrombosis.Based on the information received the cause cannot be determined; however, patient factors may have contributed to the event.If additional information is received a supplemental mdr will be submitted.

Event Description

Through follow up with healthcare provider edwards learned the 25mm valve was explanted due to severe aortic valve insufficiency.The aortic valve was inspected and found to have severe pannus and thrombus around the leaflet.One of the leaflets was folded over, and had significant thrombus.It was not mobile.The patient was transferred to the intensive care unit bed in stable but guarded condition.Patient tolerated the procedure well.Patient was discharged on post operative day four.

• Brand Name: CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ 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: 6593805
• MDR Text Key: 76045424
• Report Number: 2015691-2017-01501
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2020
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR