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

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457)

Patient Problem Aortic Regurgitation (1716)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Device was returned as is pending evaluation.Udi number: (b)(4).The device was returned to edwards for evaluation.A supplemental mdr will be submitted when new information becomes available.The cause of the event cannot be determined.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

Edwards received information a 23mm aortic valve was explanted after an implant duration of 13 days due to severe intravalvular issue causing wide open aortic insufficiency with one of the leaflets (non-coronary) not closing., the explanted device was replaced with a 25mm aortic pericardial valve.The surgeon commented that the root was highly calcified and he used a corenot to secure the valve.Upon inspection of the valve on the original surgery the surgeon said he saw nothing abnormal and the valve looked to be seated properly and functioning normally.They did not see anything concerning on the intra-operative echo.A few days postop the patient presented with dyspnea and was sent for an echo and a ct scan.The echo appeared to show ai and the ct scan appeared to show one of leaflets (non-coronary) not closing.They determined there was a severe intravalvular issue causing wide open ai.The surgeon reoperated on the patient on post-operative day 13.Upon inspection of the original valve the leaflets appeared to be functioning and closing properly.The patient is currently doing well with the 25mm aortic valve that was implanted.

Event Description

Through follow up it was learned the 23mm aortic valve was explanted after an implant duration of 10 days days due to severe intravalvular issue causing wide open aortic insufficiency with one of the leaflets (non-coronary) not closing.And perivalvular leak (pvl).Although initially the patient's post operative course was normal, patient developed signs and symptoms of left ventricular systolic heart failure.Upon inspection of the original valve the leaflets appeared to be functioning and closing properly.The aortotomy did not reveal any defect in the prosthesis, interference with the device or loose suture line.All the sutures except one, which was slightly loose, of the corknots were snug and were removed.The surgeon explanted the valve and pericardial patch and replaced it with 25mm aortic valve and new bovine pericardial patch.Tee revealed aortic prosthesis to be well seated with no insufficiency.Patient was discharged in stable, satisfactory condition 11 days after undergoing re-do aortic valve replacement.

Manufacturer Narrative

H3.Device evaluation: customer report of "intravalvular issue causing wide open aortic insufficiency with one of the leaflets (non-coronary) not closing" could not be confirmed through visual observations.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Minimal host tissue overgrowth was observed on the outflow stent circumference of the valve.No other visible inconsistencies were observed on the valve.Suture holes were observed around the sewing ring.H10.Additional manufacturer narrative: added information to a4, b5, b6, b7, d4, f10, h3, h4, h6.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.Customer reported could not be confirmed through visual observations.The returned device is undergoing further evaluation.A supplemental mdr will be submitted as additional information is received.H11.Corrected data: corrected d7.

Manufacturer Narrative

H10.Additional manufacturer narrative: added information to h10 and h6 result code.Functional testing was performed in a pulse duplicator under simulated normal physiological conditions.The motion of all three leaflets was normal; none of the leaflets remained open and none of the leaflets presented with restricted motion.There was no central leakage path evident.The total regurgitant fraction (trf) measured during pulsatile flow testing was 3.1%, which is more than three times lower than the 10% maximum allowed for a valve this size per iso (b)(4).Static leakage testing was performed in a steady backpressure leakage tester under pressures of 40, 80, and 120 mmhg.All three leaflets were observed to close under all backpressures.The reported ¿severe intervalvular issue causing wide open aortic insufficiency with one of the leaflets (non-coronary) not closing.¿ reported in vivo was not reproduced during the standardized pulsatile testing under simulated normal physiological conditions, or in the steady backpressure leakage testing.The results from in vitro testing may be different from those obtained clinically due to hemodynamic and environmental differences.Based on the information provided and evaluation of the returned device, patient and/or procedural factors may have caused or contributed; however, a definitive root cause cannot be conclusively determined.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA
• MDR Report Key: 10925455
• MDR Text Key: 218926944
• Report Number: 2015691-2020-14775
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2020

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 Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/02/2020; 02/09/2021
• Supplement Dates FDA Received: 12/16/2020; 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 82