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

Model Number 11500A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Low Cardiac Output (2501)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation.Attempts to retrieve the device is in process.If additional information is received a supplemental mdr will be submitted.Partial or total occlusion or obstruction of the coronary ostia is a recognized complication of an aortic valve replacement it is typically the result of a technical error during valve implant and not related to a product malfunction.However, partial, or total occlusion of the ostia, if unrecognized, can result in angina, myocardial infarction, acute ventricular dysfunction and/or death.The cause of the event cannot be determined at this time; however, patient and/or procedural factors likely contributed to the 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.

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional customer complaint.The information reported may or may not be related to the edwards device.Through implant patient registry, it was reported that a 25mm aortic valve was explanted at implant due to strut impingement of left main.The explanted device was replaced with a 23mm aortic valve.The 25mm valve function looked normal, biventricular function looked normal.Surgeon was about to close the chest when patient suddenly developed severe global biventricular dysfunction and after some improvement with inotropic support profound regional wall motion abnormalities were noted.Patient was placed back on bypass and on iabp.Patient underwent coronary artery bypass grafting lima to lad.When patient was taken off pump but patient developed acute biventricular failure of left main territory again.It was thought the 25mm aortic valve strut was impinging left main somehow so patient was placed back on bypass third time.The 25mm valve was explanted and replaced with a 23mm aortic valve.Records noted the case was substantially more difficult due to distorted anatomy, tissue friability, and serious medical conditions of the patient.The patient tolerated the procedure well.Patient was transferred to the intensive care unit in satisfactory condition.Patient was discharged home on post operative day eight (8).

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 cause of the event was likely due to procedural related factors.

• 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: gail warner ; 1 edwards way; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12601819
• MDR Text Key: 277646406
• Report Number: 2015691-2021-05585
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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
• Patient Age: 68 YR
• Patient Sex: Female