MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number 3300TFX

Device Problems Fluid/Blood Leak (1250); Inadequacy of Device Shape and/or Size (1583); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.The device is listed as available.A supplemental mdr will be submitted as new information is received.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 3300tfx aortic valve was explanted after implant due to intravalvular leak (one of the leaflets appeared to not be functioning well) and due to valve size being too small.Patient underwent aortic valve replacement with 25mm 3300tfx and left atrial appendage ligation with atrial clip.Surgeon feels this particular valve was mis-sized by manufacturer.Tee guidance confirmed good function, no perivalvular leak.Once protamine was administered and patient was decannulated it was found there was intravalvular leak noted and one of the leaflets was not functioning well.The valve was explanted and found to look normal and have no evidence of leaflet tethering or structural problem.The explanted device was replaced with a 25mm 3300tfx.The patient remained in icu on ventilator- no surgical complications.

Manufacturer Narrative

H10: additional manufacturer narrative: updated section: h3 (device evaluated by manufacturer), and h6 (type of investigation) product evaluation: the customer report of intravalvular leak and valve sizing issues could not be confirmed through visual observations.

Manufacturer Narrative

H10.Additional manufacturer narrative: the device history record 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.H3.Evaluation: customer report of intervalvular leak and valve sizing issues could not be confirmed through visual observations.X-ray demonstrated wireform intact.All three leaflets had serrated mechanical damage on the outflow surfaces.Suture holes were visible around the sewing ring.Sewing ring was cut around commissure 3.The external sewing ring diameter measured to be approximately 28 mm and the internal stent diameter measured to be approximately 22 mm.No intraoperative echocardiogram was provided, thus, the behavior reported in vivo could not be confirmed.A review of the manufacturing and inspection records related to this device was completed, and the results show that the device met all manufacturing specifications and inspections.The reported surgeon feels this particular valve was mis-sized by manufacturer was not confirmed.Sizing is a function of the prosthetic valve and the adjacent anatomy.Since only the valve was returned to edwards, no statement can be made concerning the sizing of the valve.Functional testing was performed in a pulse duplicator under simulated normal physiological conditions and in a steady backflow leakage tester.The leaflets all functioned well, opening and closing normally.The total regurgitant fraction (trf) of the valve as received was 8.9 percent, which is lower than the 10 percent allowed for a valve this size per iso 5840-2:2021.No visible central leakage pathway was evident during pulsatile testing.Therefore, the leakage measured in the pulsatile flow test is likely through the damaged areas of the sewing ring and/or around the valve.The reported intervalvular leak was not reproduced in the standardized pulsatile testing performed at edwards under simulated normal physiological conditions.The results from in vitro testing may be different from those obtained in the operating room due to hemodynamic and environmental differences.Per ifu, the specification for the external sewing ring diameter of 3300tfx23mm is 28mm, and the internal stent diameter is 22mm.Measurements performed in product evaluation align with nominal measurements provided in the ifu.Therefore, the customer allegation that the valve was not manufactured to the correct size was not confirmed.A definitive root cause for the reported intervalvular leak in vivo could not be conclusively determined, however it may have been due to patient and/or procedural factors.Based on the information available, a manufacturing defect has not been confirmed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; 1 edwards way; irvine, CA 92614 ; 9492504062
• MDR Report Key: 12451289
• MDR Text Key: 273100206
• Report Number: 2015691-2021-05097
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White