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

Model Number 7000TFX29

Device Problems Degraded (1153); Leak/Splash (1354); Incomplete Coaptation (2507); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Valve Stenosis (1717); Insufficiency, Valvular (1926); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.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.The root cause of this event cannot be conclusively determined with the available information.However, the degeneration exhibited by the bioprosthetic valve in this case was 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 remains implanted and cannot be evaluated.Despite multiple attempts for the product the device was not returned.The device history record (dhr) was not reviewed as the device serial number was not provided.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

Through review of medical article "mitro-aortic valve-in-valve procedures: many challenges in little space" authors marco gennari et al, the following event was identified as pertaining to edwards devices: a (b)(6) year-old patient underwent surgery for double valve in valve replacement in aortic and mitral position after an implant duration of approximately 18 years.(b)(6): the 25mm magna valve in aortic position was replaced due to degeneration leading to severe aortic stenosis (mean gradient 50 mmhg, aortic area 0.55 cm^2) and mild insufficiency.A 26mm sapien 3 valve was implanted in replacement.(b)(6): the 29mm magna valve in mitral position was replaced due to degeneration leading to severe mitral stenosis (mean gradient 12 mmhg, mitral area 0.76 cm^2) and mild insufficiency.A 29mm sapien 3 valve was implanted in replacement.The postoperative course was uneventful, and the patient was quickly discharged home.The 30 days echocardiogram showed improvement of the left ventricular ejection fraction (ef 38%), good functioning of the two transcatheter valves without significant paravalvular leakage.At 2 years follow-up, the patient presents at nyha class ii.The latest echocardiograms showed further improvement of the ef (50%), reduction of the left ventricular dimensions, and low transvalvular gradients (12 mmhg and 3 mmhg for the aortic and mitral, respectively).

Manufacturer Narrative

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

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10393433
• MDR Text Key: 203125151
• Report Number: 2015691-2020-13028
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7000TFX29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR