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

Model Number 11500A25

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Thrombus (2101); No Code Available (3191)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

The explanted valve has been returned for evaluation.Device evaluation anticipated, but not yet begun.A supplemental report will be submitted once the evaluation has been completed.

Event Description

It was reported that a 25mm pericardial aortic valve was explanted.After chest closure, the patient had coded and was the chest was reopened.The 25mm 11500a valve was explanted due to clot or thrombus observed on the inflow side of the leaflets.The explanted valve was replaced with a 23mm 3300tfx pericardial aortic valve.Per the operative report, post insertion of the 25mm 11500a valve, probing showed no perivalvular leaks, and the left main and right coronary ostia were both probed and found to be patent.After separation from cardiopulmonary bypass (cpb), the patient did well.Extra time was taken to ensure hemodynamic stability, and there was good right and left ventricular function, which was in fact found.Protamine was administered, but several minutes into administering, the right ventricle became somewhat hypokinetic and this was confirmed on tee.The patient was not on any inotropic support at that point, so epinephrine was initiated along with milrinone.The heart function improved, but since there was question of the status of the small right coronary osita from the outset, a decision was made to performed cabg.Patient was separated from cpb, which had been re-instituted for grafting without difficulty.Protamine was re-administered, and after achieving hemostasis, the chest was closed in standard fashion.Approximately 5 to 10 minutes after chest closure, the patient's blood pressure abruptly dropped without any discernible cause.Patient did not respond to pressor or inotrope support; therefore, chest compressions were initiated by tee.There was minimal cardiac function and no discernible rhythm.Chest compressions were initiated and chest was re-opened, and the patient was returned to cpb.It was decided to removed the 25mm aortic valve in case there was any compromise of the left main and/or right coronary ostia, the right ostium having already been protected with the previously placed vein graft.Prior to removing the valve, the left main was able to be probed easily and it was visibly clear and patent.Inspection of the left main coronary ostium did not show any significant issues.The right coronary ostium was quite compromised by removal of the initial non-edwards valve.Of note, is that the underside of the inspiris valve was coated with fibrinous white-yellow material, which was densely adherent already to the newly inserted valve.This material was not apparent on the aortic side of the leaflets (this was another reason why the valve was removed) as there was no telling why the patient's acute arrest occurred on d one potential source would have been embolism from the undersurface of the valve from this clearly thrombotic material.Given the complexity of the situation, the valve was downsized and a 23mm 3300tfx aortic valve was implanted in replacement.After separating from cpb with new valve in place, the left ventricular function gradually improved with still some global hypokinesis despite inotropic and pressor support.Therefore, another cabg was performed with excellent result.Patient was found to have excellent left and right ventricular function with no evidence of abnormality.The patient was able to easily separate from cpb and protamine was administered.The patient was transferred to the icu in critical, but stable condition with excellent biventricular function, excellent urine output throughout the case, and good brain saturations.

Manufacturer Narrative

Evaluation summary: customer report of thrombus was confirmed through observed thrombus.X-ray demonstrated wireform intact and cocr band to remain intact; the vfit cocr alloy band was not expanded.Fibrin/thrombotic material was observed on all three leaflets at the inflow aspect near commissures 1 and 2 and along the free margins.The fibrin-like deposition was found to be adhered to the inflow surface of the leaflets and was more notable at the commissural areas and near the valve frame.The deposition on the outflow (aortic) side of the valve is unremarkable.Radiograph demonstrated that the valve size is 25 mm and the vfit cocr alloy band was intact with no evidence of expansion.The fibrin-like deposition on bovine bioprosthetic heart valve as observed on this particular valve is uncommon.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.It was reported that on explant the valve was observed to have adhesion of fibrinous material on the ventricular side of the valve.In this case, the root cause of this event cannot be determined with the available information at this time.It is unknown whether patient and/or procedural related factors may have caused or contributed to the event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

The reported event was not confirmed through preliminary evaluation of the explanted valve.The device has been sent for further testing and analysis.A supplemental report will be submitted accordingly once the evaluation has been completed.

Manufacturer Narrative

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

• 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: 8608549
• MDR Text Key: 145082684
• Report Number: 2015691-2019-01726
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2020
• Device Model Number: 11500A25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 05/14/2019; 06/04/2019; 07/23/2020
• Supplement Dates FDA Received: 06/03/2019; 06/19/2019; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR