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

Model Number 11500A

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

In this case, it was reported the post-operative echo showed a floating substance-like material that was observed to be attached to a leaflet of the valve.The reported event cannot be confirmed since the device remains implanted in the patient.However, it was reported that the device was inspected before use but there was no abnormality observed.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards lifesciences will continue to monitor all reported events.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

Edwards received information that floating substance-like material was observed to be attached to a leaflet of this 19mm inspiris resilia aortic valve on post-operative echo.The device was inspected before use but there was no abnormality observed.This patient receives hemodialysis treatment and does not have infective endocarditis nor vegetation.Since the patient condition is well, no intervention is planned.There is no patient injury reported.

Manufacturer Narrative

Post-pump intraoperative tee images and videos taken the same day of the procedure were provided.At an unknown interval following bioprosthetic aortic valve replacement, a 5-10 mm highly mobile soft tissue-density mass is noted echocardiographically on the aortic aspect of the bioprosthesis.In general, a mobile mass with this appearance could represent thrombus or vegetation (infective or non-infective); however, vegetation would be expected to take somewhat longer than thrombus to form.A mass of this size presumably would have been visible during valve inspection at the time of implantation, suggesting that it formed after implantation.Since the second tee was taken post-pump intraoperatively (immediately after valve implantation), then thrombus (variably either platelet-rich or fibrin-rich) is most likely.What is visualized is a long, thin, mobile mass; and not consistent with ¿particulate contamination.¿ 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, the patient was reported to be doing well.There is no plan for any intervention at this time.

Manufacturer Narrative

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

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8096375
• MDR Text Key: 129048750
• Report Number: 2015691-2018-04853
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1