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

Model Number 7300TFX23

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

Patient Problems Corneal Pannus (1447); Mitral Valve Stenosis (1965)

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the x-ray demonstrated moderate to heavy calcification on all three leaflets, wireform intact, and commissure 3 was bent.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 5mm on leaflet 2 at the inflow aspect.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 5mm on leaflet 3 at the outflow aspect.Host tissue fused leaflets 1 and 2 by approximately 4mm near commissure 2 on outflow aspect.Leaflet 2 had a tear of 4mm along commissure 3.The leaflet tear was in the same region as the cloth tear on commissure 3.The sewing ring was cut around leaflet 1, and the wireform was exposed around leaflet 1 and on commissures 1 and 3.Additional manufacturer narrative: customer report of stenosis was confirmed.Calcification and host tissue restricted leaflet mobility, and likely led to the reported stenosis.Although bioprosthetic valves have been proven to have excellent long term durability, failure does occur in a small number of valves.Calcification is a well recognized failure mode of bioprosthetic valves.The mechanisms for bioprosthetic heart valve tissue calcification are not fully understood.Many factors can contribute to the onset and propagation of calcification including patient related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.Host tissue/pannus growth likely contributed, to a lesser degree, to this explant.Host tissue 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.According to literature, pannus typically occurs between 12 months to 5 years.Since the mechanism of host tissue growth in bioprosthetic heart valves is still not fully understood, the root cause for the host tissue growth for this particular valve cannot be determined at this time.The root cause for the calcification and pannus remains indeterminable.However, it is likely that patient related factors and progression of the underlying valvular disease pathology contributed to the event.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.No corrective action is applicable to this case; however, 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.No corrective or preventative actions are required.

Event Description

Edwards received information that this 27mm mitral pericardial valve, implanted approximately three (3) years, was explanted due to mitral stenosis.The surgeon reported that there was a risk of early deterioration due to the patient being at a younger age at implant and on dialysis.However, three years from the implant date was noted to have been earlier than expected.The explanted device was returned for evaluation.

Manufacturer Narrative

The device history record 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.

• Brand Name: CARPENTIER-EDWARDS® PERIMOUNT® MAGNA MITRAL EASE¿ PERICARDIAL BIOPROSTHESES
• 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: trushala nerurkar ; one edwards way; m/s lfs-33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6139925
• MDR Text Key: 61291440
• Report Number: 2015691-2016-03538
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860057/S068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2016
• Device Model Number: 7300TFX23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2012
• 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: 57 YR
• Patient Weight: 52