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

Model Number 7300TFX27

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

Stenosis and/or regurgitation, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis and/or regurgitation.The root cause of this event cannot be conclusively determined with the available information.However, the stenosis and regurgitation in this case were most likely impacted by the progression of the patient¿s underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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 27mm 7300tfx (cp-2020-10235-1) pericardial mitral valve underwent a valve-in-valve procedure after an implant duration of seven (7) years, 10 months due to severe symptomatic mitral stenosis regurgitation.The tmvr procedure was performed with a 29mm 9600tfx transcatheter valve.A small anteriorly directed paravalvular leak was noted.The patient was taken to the icu in stable and awake condition.There were no complications and the procedure was tolerated well.The patient was discharged home on pod #2 in stable condition.Per received medical records it was learned that the patient's 21mm 3300tfx (cp-2020-10235-2) pericardial aortic valve had exhibited severe dysfunction and had undergone valve-in-valve intervention after an implant duration of approximately seven (7) years, eight (8) months.The tavr procedure was noted to have been uneventful.Model number and size of the transcatheter valve implanted in the aortic position is unknown.The patient was noted to have been doing well in the two (2) months prior to the tmvr procedure.

Manufacturer Narrative

Updated: h6.

Manufacturer Narrative

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

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10226256
• MDR Text Key: 199991627
• Report Number: 2015691-2020-12407
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2016
• Device Model Number: 7300TFX27
• 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: 81 YR