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

Model Number 8300AB

Device Problem Central Regurgitation (4068)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device is in process.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

Through implant patient registry, it was learned a 27mm 8300ab aortic valve was explanted after implant duration of four (4) years, due to severe aortic insufficiency.The explanted device was replaced with a 25mm 11500a aortic valve.Patient presented with heart failure, dyspnea.Patient underwent concomitant coronary artery bypass during the operation.Per medical records, patient was transferred to icu for complete heart block and concern for cardiogenic shock and was started on inotropic support.Patient underwent re-do avr and tolerated the procedure well and was transferred to icu intubated and hemodynamically stable.On pod # 3 patient underwent ppm replacement.Patient was discharged home in good condition on pod #16.Per pathology report, the outflow surface of the bioprosthetic valve demonstrated focal areas of atheromatous changes and calcification.

Manufacturer Narrative

The device history record 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.The most likely cause is patient factors, including native bicuspid aortic valve (bav), hyperlipidemia (hld), and chronic kidney disease (ckd).

• 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18588987
• MDR Text Key: 333900037
• Report Number: 2015691-2024-00619
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2021
• 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: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2017
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male