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

Model Number 3000TFX19MM

Device Problems Incomplete Coaptation (2507); Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.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, pannus can have both beneficial and harmful effects depending on the amount of growth.A small amount of host tissue growth over the suture line is needed to form a nonthrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.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 cannot be determined at this time.The subject device was not returned for evaluation as it remains implanted in the patient; therefore, the complaint cannot be confirmed.However, clinical observation was able to confirmed through review of received medical records.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.In this case, a definitive root cause for early calcification and pannus could not be conclusively determined.However, there are no indications of a manufacturing defect.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a patient with a 19mm 3000tfx pericardial aortic valve underwent a valve-in-valve procedure after an implant duration of three (3) years, six (6) months due to pannus growth on leaflets resulting in severe aortic stenosis and regurgitation.The tavr procedure was performed with a 23mm 9750tfx transcatheter valve.Post-deployment bav was performed to expand the transcatheter valve further and fracture the surgical valve.There were no procedural complications.Echo showed no pvl or aortic insufficiency.The patient tolerated the procedure well and was sent to the pacu in stable condition.The patient was discharged home on pod #1.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10398596
• MDR Text Key: 203153966
• Report Number: 2015691-2020-13048
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2019
• Device Model Number: 3000TFX19MM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 56