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

Model Number 8300AB

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2022

Event Type  Injury  

Event Description

Edwards received notification a patient with an elite valve model 8300ab21 underwent an intervention to treat a paravalvular leak (pvl) +3 four (4) days after the implantation of the device.The surgeon reported a partial inflation of the device.The frame of the valve was observed to be irregular and not correctly deployed at the time of implantation due to a heavy calcified irregular aortic annulus and root, in a small aortic root.Hypertrophic septum.Valve seating was difficult due to the large amount of calcium and not easy angle for valve exposure (also after ascending aorta reconstruction).No pop up and no valve displacement were observed after frame expansion.Medical treatment was provided but as there was no significant improvement in patient's symptoms, a pvl closure was planned.The aortography confirmed an inadequate frame expansion.The patient underwent a high-pressure balloon valvuloplasty and implantation of an occlutech device to fix the paravalvular leak.After the procedure, the patient was noted as to be stable with moderate residual leak.The outcome of the patient was noted as to be going better, extubated and hospitalized stable.As reported, the device did not cause or contribute to the event and there was no allegation of device malfunction.

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned for evaluation, as it remains implanted.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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

H10: additional manufacturer narrative: added information to section d4 (expiration date) and h4 (device manufacturer date) updated section b4 (date of this report), g3 (date received by manufacturer), h6 (component code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).No product, medical records, or imaging was returned for evaluation.The device history record (dhr) review was performed and no relevant non-conformances were identified.The reported paravalvular leak was caused by under expansion of the frame.Based on the information available, this is due to incorrect seating of the valve for which the most likely cause is operational factors, including the patient's irregular, heavily calcified aortic annulus and root and difficulties angling the valve after ascending aorta reconstruction.An edwards defect has not been confirmed.

• 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: reginald santos ; 1 edwards way; ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15579185
• MDR Text Key: 301562354
• Report Number: 2015691-2022-08487
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 104 KG