MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; REPLACEMENT HEART VALVE

Model Number 11500A21

Device Problems Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Death (1802); Thrombosis (2100)

Event Date 06/12/2019

Event Type  Death  

Manufacturer Narrative

Valve thrombosis is a rare and well-recognized complication of prosthetic valves.Valve thrombosis is the formation of significant blood clots forming on the valve.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Immediate intervention, either by thrombolytic therapy or valve replacement is required for significant thrombosis.Alternatively, there may be cases where the patient is placed on an anticoagulant to treat thrombosis.In this case, surgical intervention was indicated but the patient expired.Minimal information was received in this case and attempts to get additional information regarding the condition of the device, device return, patient's medical history, or possible comorbidities are in progress.If new information becomes available, a supplemental report will be submitted.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.

Event Description

It was reported a patient, implanted with a 21 mm aortic valve for 15 days, presented emergently with chest pain.The valve was found to have thrombosis and vegetation on it.No secondary intervention was attempted or completed.The patient was reported to have expired.

Manufacturer Narrative

Udi # : (b)(4).

Manufacturer Narrative

Edwards received additional information through follow up with the healthcare provider.Supplemental report submitted to update.Based on the available information, the root cause of the event remains indeterminable.However, it is likely that patient related factors and the progression of the patient's underlying valvular disease pathology contributed to the event.

Event Description

It was reported a patient, implanted with a 21mm aortic valve for 15 days, presented emergently with chest pain.The valve was found to have thrombosis and vegetation on it.No secondary intervention was attempted or completed.The patient was reported to have expired.Per obtained medical records, during the initial implant surgery, the 21mm aortic valve was implanted successfully with no perivalvular leak and a postoperative mean gradient of 6mmhg.The patient was discharged home in stable condition on post-operative day four.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa: 20-00141.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8760090
• MDR Text Key: 150014673
• Report Number: 2015691-2019-02486
• Device Sequence Number: 1
• Product Code: LWR
• 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,Followup,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 11500A21
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR