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

Model Number 3300TFX21MM

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

Udi #: (b)(4).Stenosis, 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.The root cause of this event cannot be conclusively determined with the available information.It is unknown whether patient and/or procedural related factors may have caused or contributed to the event.The subject device is not available for evaluation, as it remains implanted in the patient.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 this patient with a 21mm pericardial aortic valve has been placed under consideration for a valve-in-valve procedure after an implant duration of one (1) year, 11 months due to aortic stenosis.There was no allegation of device malfunction.No additional information was provided.

Manufacturer Narrative

Additional manufacturer narrative: additional information was received and the following section(s) was updated: sections event, other relevant history, (expiration date), (device code), device manufacture date.Corrected data: updated sections event, outcomes attributed to adverse event, (additional manufacturer narrative) patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.Ppm has been shown to be associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival.It is typically not related to product malfunction.In this case, the root cause of the prosthetic mismatch was likely due to patient and/or procedural related factors.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.There were no issues identified that would have impacted this event.The ifu was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.

Event Description

It was reported that this patient with a 21mm pericardial aortic valve has been placed under consideration for a valve-in-valve procedure after an implant duration of one (1) year and 11 months due to patient prosthetic mismatch and severe aortic stenosis.There was no allegation of device malfunction.

Manufacturer Narrative

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

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8378494
• MDR Text Key: 137955105
• Report Number: 2015691-2019-00674
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S042
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 3300TFX21MM
• 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; Other; Required Intervention
• Patient Age: 75 YR