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

Model Number 7000TFX27

Device Problems Calcified (1077); Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Calcium Deposits/Calcification (1758); No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2020

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/replacements 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.In this case, calcification was indicated.Calcification plays a major role in the failure of bioprosthetic heart valves.Calcification of valves occurs as a progressive, time-dependent process.Tissue valve calcification is initiated primarily within residual cells that have been devitalized.Initial calcification deposits eventually enlarge and grow into a mass, which stiffen and weaken the tissue and thereby cause the prosthesis to malfunction.The mineralization of a biomaterial is generally enhanced at the sites of intense mechanical deformations generated by motion, such as the points of flexion in heart valves.Ultimately, the result of calcification is valve failure due to tearing or stenosis.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to anti-calcification treatments during manufacturing.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 bioprosthesis from calcifying.The device was not returned for evaluation.As the patient had undergeone a valve-in-valve procedure the device remains implanted.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.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

Edwards received notification that this (b)(6) y-o patient with a valve model 7000tfx27 implanted in the tricuspid position underwent a procedure for a valve-in-valve replacement after an implant duration of 8 years and 7 months due to calcific degeneration of leaflets.A 29mm sapien3 valve was implanted within the edwards surgical device with a perfect result.After the procedure the patient was noted as to be hospitalized in stable condition.The surgeons commented they were satisfied of the durability of the edwards valve, given the young age of the patient.

Manufacturer Narrative

Updated: b4, g4, h6.

Manufacturer Narrative

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: 10320748
• MDR Text Key: 200414359
• Report Number: 2015691-2020-12676
• 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,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2015
• Device Model Number: 7000TFX27
• 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: 32 YR
• Patient Weight: 90