MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300AB

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

H10.Additional manufacturer narrative: the device was not returned for evaluation, as the device request is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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

Edwards received notification that paravalvular leak was still present one week after the implantation of an elite valve model 8300ab23.As reported, the cardiologists tried a valvuloplasty, but it was not successful because could not pass the valve and kept getting into the pvl.So the cardiologists would try with a plug.Reportedly, the surgeons had to wait too long for the cardiologists implanting the plug so they reoperated the patient.During the reoperation it was observed that the right coronary stitch was loose and that caused a big aortic leak.

Manufacturer Narrative

Added information to section b7 (additional text), d4 (expiration date), d4 (serial number), d6 (implanted, give date) and h4 (device manufacturer date).Updated section b4 (date of this report), b5 (describe event or problem), g3 (date received by manufacturer), h6 ( device code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).H10: additional manufacturer narrative: the device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Device dehiscence or suture torn out may occur early or late.When it occurs in the intraoperative period, it is typically a result of inadequate device implantation in combination with friable myocardial tissue.Valve dehiscence is not a malfunction related to a manufacturing deficiency of the device.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is procedural factors, including the right coronary stitch that was loose causing the big aortic insufficiency.

Event Description

Edwards received notification that an elite valve model 8300ab23 implanted in aortic position was explanted after seven (7) days due to paravalvular leak.As reported, the cardiologists tried a valvuloplasty the same day of the initial procedure, but it was not successful because the guide wire every time went into the perivalvular leak (pvl) instead of through the valve and the pvl was still present.So the cardiologists would try with a plug.Reportedly, the surgeons had to wait too long for the cardiologists implanting the plug so they reoperated the patient after seven (7) days of initial procedure.During the reoperation it was observed that the right coronary stitch was loose and that caused a big aortic insufficiency.During the initial surgical intervention a left ventricular assist device (lvad) was put in place.At the second surgical intervention a right ventricular assist device (rvad) was put in place as well.Few days after the patient died.The cause of death was not provided.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18564881
• MDR Text Key: 333493196
• Report Number: 2015691-2024-00542
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization