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

Model Number 11500A

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

Patient Problems Thrombus (2101); Injury (2348)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned to edwards for evaluation.The device history record (dhr) 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.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/ring.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.A manufacturing related issue was not identified.A definitive root cause could not be determined.A supplemental mdr will be submitted upon completing of device evaluation.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that this 23mm valve was explanted few hours after implantation due to a ventricle perforation that needed to be repaired.As reported the perforation occurred just below the left coronary annulus; the valve was explanted to reach and repair the perforation with a patch.As reported the issue was not due to the edwards device.The explanted device was replaced with a 21mm valve.The patient was noted as to be doing fine and recovering.No problem occurred during implantation.As reported, on explant the valve looked fine, but some "thrombogenetic coating" was observed on one leaflet.

Manufacturer Narrative

H3.Device evaluation: customer report of ventricle perforation could not be confirmed through visual observations.Report of "thrombogenetic coating" on valve leaflet was confirmed.As received, fibrin-like thrombotic material was observed on the surfaces of all three leaflets at both the inflow and outflow aspects.The fibrin-like thrombotic material was moderate on the outflow aspect and encroached onto the tissue and into the orifice at the greatest distance of approximately ­­7mm on leaflet 3.The fibrin-like thrombotic material was minimal on the inflow aspect and encroached onto the tissue and into the orifice at the greatest distance of approximately ­­2mm on leaflet 1.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Sewing ring underneath commissure 1 was cut.H10.Additional manufacturer narrative: updated h3 and h6.

Manufacturer Narrative

H10.Additional manufacturer narrative: update h6 (result and conclusion).

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10467511
• MDR Text Key: 204916103
• Report Number: 2015691-2020-13353
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2022
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 53 YR