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

Model Number 11500A

Device Problem Malposition of Device (2616)

Patient Problems Myocardial Infarction (1969); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: 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 root cause of this event cannot be determined with the available information.It is unknown if the patient and/or procedure-related factors may have caused or contributed to this event.There has been no allegation of a product malfunction.The subject device is not available for evaluation as it was never received.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, an appropriate investigation will be performed.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

Through implant patient registry, it was learned that a patient with a 23mm 11500a aortic valve was explanted at implant due to obstruction of the coronary ostium.The explanted valve was replaced with a non-edwards valve.Per the medical records, the patient previously placed homograft was densely calcified with perforation of both the left and right leaflets.The ostia were low-lying, and a full root repair was not unexpected.The patient underwent an aortic root enlargement with a bovine pericardial patch and a 23mm 11500a was implanted.The aorta was closed but there was new lv hypokinesis and multiple arrhythmias.There was ostial obstruction, so the valve and patch were explanted.The subsequent root replacement was successful, using a 25 mm non edwards valve within a pig root, and a 26mm dacron graft.The patient tolerated the procedure well and was transferred to the icu in stable condition.On pod #4, the patient was discharged home in stable condition, on new oxygen, cardiac, antiplatelet, and diuretic therapy.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.

Manufacturer Narrative

H11: corrective data: corrected section: h6 (investigation findings, and investigation conclusions).

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11733110
• MDR Text Key: 252262858
• Report Number: 2015691-2021-02693
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: 00690103194982
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 85