MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN M3 VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9880TFX29MCLUS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/23/2022

Event Type  Injury  

Manufacturer Narrative

The complaint device, sapien m3 valve - model 9880tfx29mclus, is not sold or marketed in the us; however, it is deemed similar to the sapien 3 transcatheter heart valve - model 9600tfx29, pma # p140031.The pma/510k field will be blank.The investigation is ongoing.Device not available for return.

Event Description

As reported from a clinical trial, approximately 2 days post transseptal transcatheter mitral valve replacement (tmvr) procedure with a 29mm sapien m3 valve, it was noted that the valve was not functioning as expected.The valve appeared to be seated lower in the mitral valve annulus with avp (amplatzer vascular plug) closure device on the medial side of the annulus.A decision was made to proceed with a surgical mitral valve replacement (smvr) which was completed approximately 15 days post tmvr procedure.

Manufacturer Narrative

A supplemental mdr is being submitted to correct the reportability of the event previously reported.Per the initial report, approximately 2 days post transseptal transcatheter mitral valve replacement (tmvr) procedure with a 29 mm sapien 3 valve, it was noted that the "valve was not functioning as expected".The "valve appeared to be seated lower in the mitral valve annulus with vascular plug closure device on the medial side of the annulus".A decision was made to proceed with a surgical mitral valve replacement (smvr) procedure which was completed approximately 15 days post tmvr procedure.Additional information received via medical records clarified the patient's 29 mm sapien m3 valve was explanted due to ongoing hemolysis in the setting of residual paravalvular leak (pvl) status post vascular plug implantation.It was concluded that the valve was functioning well with no valve dysfunction.Per the instructions for use (ifu), hemolysis is a known potential adverse event associated with the transcatheter heart valve (thv) procedure and the use of the edwards thv devices.Hemolysis is the destruction of red blood cells.There are multiple extrinsic and intrinsic factors including use of extracorporeal circulation, transfusion, infection, tumors, autoimmune disorders, medication side effects, a metabolic abnormality, and red blood cell membrane instability.Normal red blood cells (erythrocytes) have a lifespan of about 120 days.After the lifespan is over the red blood cells break down and are removed from the circulation by the spleen.In some medical conditions, or because of taking certain medications, this breakdown of red blood cells is increased.Red cells may break down due to mechanical damage, such as from artificial heart valves or heart-lung bypass; or they may be destroyed due to defects in the cells themselves.Medications that have been associated with hemolysis include acetaminophen, penicillin, and other pain medications.In this case, investigation results suggest that hemolysis was the reason for the valve explantation.There was no allegation or indication a valve malfunction occurred.The complaint device, sapien m3 valve - model 9880tfx29mclus, is not sold or marketed in the us; however, it is deemed similar to the sapien 3 transcatheter heart valve - model 9600tfx29.Similar device reporting under 21cfr part 803 only requires reporting of device malfunctions and serious injuries related to device malfunctions.In this case, investigation showed a device malfunction did not occur, therefore this event is not fda reportable.

• Brand Name: SAPIEN M3 VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16352642
• MDR Text Key: 309286148
• Report Number: 2015691-2023-10725
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103214291
• UDI-Public: (01)00690103214291(17)231020
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2023
• Device Model Number: 9880TFX29MCLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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