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

Model Number 8300AB19J

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  Injury  

Event Description

Edwards received information that a patient with a 19 mm 8300ab pericardial aortic valve implanted approximately forty-nine (49) days was explanted due to moderate paravalvular leak (pvl) secondary to undersizing.A 19 mm 11500aj pericardial aortic valve was implanted in replacement.The patient status was reported as "under treatment".The device will not be returned for evaluation as it was discarded at the hospital.At sizing of 8300ab, the surgeon did not measure the patient's annulus precisely because he was afraid of adding strong tension to it.In addition, the patient was small build, the surgeon thought that the smallest 19 mm would fit.However, it was the wrong size (undersized) and resulted in pvl.There was no causal relationship between the event and the device.The device was originally implanted for aortic valve replacement to correct aortic stenosis and regurgitation.Three sutures were placed to the sewing ring.Patient's condition was stable, however, about fourteen (14) days after implant, pvl was detected, and it got aggravated.Heart failure symptom was not seen.Before 8300ab implant, there was an 19 mm non-edwards aortic prosthetic valve implanted.When the surgeon explanted the device, small annular damages were made.The damaged sites were repaired with two (2) non-everting mattress sutures with spaghettis.

Manufacturer Narrative

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

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.The most likely cause is procedural factors, including "the surgeon did not measure the patient's annulus precisely because he was afraid of adding strong tension to it.In addition, the patient was small build, the surgeon thought that the smallest 19mm would fit.".

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14399391
• MDR Text Key: 291835098
• Report Number: 2015691-2022-05705
• 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,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8300AB19J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 06/21/2022
• Date Device Manufactured: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Male