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

Model Number 2700TFX27MM

Device Problems Calcified (1077); Torn Material (3024); Insufficient Information (3190)

Patient Problems Aortic Valve Stenosis (1717); No Information (3190)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: device evaluation is still pending.A supplemental mdr will be submitted when the evaluation is complete.

Event Description

Edwards received information that a patient with a 27 mm bioprosthetic aortic valve, implanted nine years and three months, was explanted.The reason for explant remains unknown.

Event Description

Edwards received additional information through follow up with the healthcare provider that the reason for the valve explant was due to severe aortic regurgitation due to right coronary leaflet tear.The patient underwent redo sternotomy, avr with 25 mm pericardial aortic valve, mitral valve plasty with 34 mm annuloplasty ring, biatrial maze, and atriclip.There were no complications and the patient was transferred to the cticu in stable condition.

Manufacturer Narrative

Evaluation summary: x-ray demonstrated heavy calcification on leaflet 1, moderate calcification on leaflet 3, and wireform intact.As received, the sewing ring was cut off around the valve and exposed the wireform.Both bands were removed and not returned.Leaflet 1 had two tears of 5mm near commissure 1, and 6mm near commissure 2.Leaflet 2 had a 3mm tear near commissure 2.Leaflet 3 had a tear of 4mm near commissure 3, and a 3mm non-transmural tear at the inflow aspect near commissure 1.Calcification was evident near the tears on leaflet 1, and on leaflet 3 near commissure 3.Tissue thickening and swelling was also observed on the leaflets near the commissures.Additional manufacturer narrative: calcification is a well-recognized failure mode of bioprosthetic valves.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.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.Based on the product evaluation, the root cause for the calcification remains indeterminable.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

• Brand Name: CARPENTIER-EDWARDS® PERIMOUNT THEON¿ PERICARDIAL BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7273841
• MDR Text Key: 100178880
• Report Number: 2015691-2018-00533
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2010
• Device Model Number: 2700TFX27MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR