MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A

Device Problem Difficult to Open or Close (2921)

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

Event Type  Injury  

Event Description

Edwards received information that a patient with a 19mm 11500 aortic valve implanted approximately fifty-four (54) days was explanted due to aortic stenosis and moderate to severe regurgitation.The jet was from the commissure between the right and the non-coronary cusps detected by the echo image.There were no patient symptoms.The device was replaced with a 19mm non-edwards mechanical valve without any adverse event reported.There was no visual abnormality observed on the explanted valve.Per the report from the physician, one leaflet was in open position and the other two leaflets were in closed position.He suspected that the distortion of the cobalt-chromium alloy band which was either from the beginning or caused by knotting the suture ring contributed to develop asr.The patient status was reported as recovered.

Manufacturer Narrative

Surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was returned and product evaluation 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.

Manufacturer Narrative

H11.Additional narrative: updated h3 and h6 per new information.Product evaluation: customer reports of stenosis and regurgitation were unable to be confirmed.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Suture holes were visible around the sewing ring.No other visible inconsistencies were observed from the valve.

Manufacturer Narrative

Product evaluation: customer reports of stenosis and regurgitation were unable to be confirmed.The x-ray demonstrated commissures 1 and 3 were bent inward and leaflet 3 was wavy.X-ray also demonstrated the cocr band remained intact and the vfit cocr alloy band was not expanded.Suture holes were visible around the sewing ring.No other visible inconsistencies were observed from the valve.Based on the information available, a definitive root cause is unable to be determined, however, patient and/or procedural factors likely caused or contributed.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18798624
• MDR Text Key: 336456171
• Report Number: 2015691-2024-01408
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• 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,Followup
• Report Date: 05/11/2024

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 Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/18/2024; 04/22/2024
• Supplement Dates FDA Received: 04/10/2024; 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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; Hospitalization; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female