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

Model Number 7300TFX

Device Problems Restricted Flow rate (1248); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Coagulation Disorder (1779); Obstruction/Occlusion (2422); Low Cardiac Output (2501)

Event Date 01/30/2021

Event Type  Injury  

Manufacturer Narrative

Partial or total occlusion or obstruction of the coronary ostia is a recognized complication of an aortic valve replacement and, less frequently, from mitral valve replacement.It is typically the result of a technical error during valve implant and not related to a product malfunction.However, partial or total occlusion of the ostia, if unrecognized, can result in angina, myocardial infarction, acute peri-operative right, left or bi-ventricular dysfunction and/or death.In this case, lvot obstruction occurred due to oversizing of the valve and the patient was placed on ecmo.The subject device is not available for evaluation, as it was not returned for evaluation.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.The root cause of this event cannot be conclusively determined with the available information.However, this event was likely due to patient and/or procedural related factors.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.If any additional information is received, a supplemental report will be submitted accordingly.

Event Description

It was reported that this patient underwent redo-mvr and tv repair with an annuloplasty ring.Upon weaning from cpb, echocardiogram showed la was significantly dilated and there was very poor inflow to the lv across the mitral valve.The valve leaflets opened very well.Additionally, significant amount of aortic valve regurgitation was present that was not there prior.The mitral valve opened normally, but the surgeon was concerned it was perhaps over-sized, which was contributing to significant lvot obstruction and possibly compromising the aortic valve.The 27mm valve (subject device) was removed and replaced with a 25mm 7300tfx valve, which the surgeon tried to place the prosthesis in the deeper position in the ventricle to prevent any inflow problems.There were complications in weaning from cpb.There was global severe hypokinesis of the entire lv with the rv somewhat hypokinetic.The patient was on high doses of epinephrine and dobutamine without the ability to adequately wean from cpb.Based on this, it was decided to place the patient on central cannulation and va ecmo.The patient was brought to the icu in stable but critical condition.The patient's hospital course was complicated by coagulopathy.Repeat tee was notable for significant pvl.The decision was made to pursue comfort care for the patient.The patient expired on pod #5.

• 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: 11547754
• MDR Text Key: 251417878
• Report Number: 2015691-2021-02010
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103186260
• UDI-Public: 00690103186260
• Combination Product (y/n): N
• PMA/PMN Number: P860057
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2021
• Device Model Number: 7300TFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR