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

Model Number 6900PTFX25

Device Problems Folded (2630); Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Mitral regurgitation (mr) in bioprosthetic heart valves occurs when the valve does not close properly in systolic phase, which results in retrograde flow of blood into the left atrium.Trivial/trace to mild amounts of mr are not unusual in bioprosthetic valves in the immediate post-operative setting, and is usually tolerated by patients.However, if the regurgitation worsens or becomes symptomatic, reoperation may be necessary.Acute central leaks observed in the peri-operative period usually occur from technique related issues such as suture looping or chordae entrapment at the mitral position.Another technique related issue is valve distortion during implant which may result in a dropped leaflet or asymmetric coaptation.These techniques are not typically the result of product malfunction; however, they may contribute to mild to severe regurgitation and if undetected may require reoperation.In this case, it was reported that severe regurgitation was observed due to overlapping/folded leaflets.The root cause of this event cannot be conclusively determined with the available information.The subject device has not been returned for evaluation.It is unknown if procedural related factors may have caused or contributed to the event.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 notification that this patient with a 25mm pericardial mitral valve was explanted one (1) day post implantation due to overlapping/fold leaflets leading to severe regurgitation observed on echo.The valve was replaced with another edwards pericardial mitral valve of the same model and size.The patient was hospitalized in stable condition.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.The explanted valve has been returned for evaluation.The device evaluation has been anticipated, but not yet begun.A supplemental report will be submitted accordingly once the product evaluation has been completed.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.

Manufacturer Narrative

Evaluation summary: customer report of suture looping was confirmed.Report of regurgitation was visually confirmed due to suture looping.Suture track indentations were observed on leaflets 1 and 3 near commissure 1.This indicated that the suture was looped around commissure 1, thus leading to the reported regurgitation.X-ray demonstrated wireform intact.Thrombotic-like material was observed on the inflow aspect of the leaflets.It was learned that the surgeon suspected suture looping had caused the reported regurgitation.It was also indicated that the edwards tricentrix holder was not used in this procedure.Per the device instructions for use: to avoid suture looping, it is essential to leave the deployed [tricentrix] holder in place until all knots are tied.In this case, it was reported that the tricentrix holder was not used during implantation of the subject device.It has been determined that the root cause of this event was due to user error.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7430779
• MDR Text Key: 105507506
• Report Number: 2015691-2018-01390
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S022
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2021
• Device Model Number: 6900PTFX25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR