MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART VALVE

Device Problems Incomplete Coaptation (2507); Activation, Positioning or Separation Problem (2906); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Tricuspid Regurgitation (2112); Tricuspid Valve Stenosis (2113)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The root cause of this event cannot be conclusively determined with the available information.However, the stenosis in this case was most likely impacted by the progression of the patient¿s underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) could not be reviewed, as the device serial number was not provided.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.

Event Description

It was reported that this patient with a 35mm edwards porcine valve, implanted in the tricuspid position, underwent a valve-in-valve procedure after an unknown implant duration due to tricuspid stenosis.An attempt of the ttvr was performed via jugular access, but the edwards transcatheter valve could not be deployed.The following day the ttvr procedure was successfully completed through transfemoral access resulting in the implant of a 29mm edwards transcatheter valve.

Manufacturer Narrative

Stenosis and/or regurgitation, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis and/or regurgitation.The root cause of this event cannot be conclusively determined with the available information.However, the stenosis and regurgitation in this case were most likely impacted by the progression of the patient¿s underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) could not be reviewed, as the device serial number was not provided.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.

Event Description

It was reported that a patient with a 35mm edwards porcine valve, implanted in the tricuspid position, underwent a valve-in-valve procedure after an implant duration of approximately eight (8) years and three (3) months due to tricuspid stenosis and tricuspid regurgitation.An attempt of the ttvr was performed via jugular access, but it was aborted as the surgeon was unable to pull the balloon into the valve.The transcatheter valve was removed.The following day, a second attempt of the ttvr procedure was successfully completed with transfemoral access resulting in the implant of a 29mm edwards transcatheter valve.The patient was transferred to the picu post procedure.The patient's post operative course was complicated by hemodynamic instability and liver dysfunction.The patient was discharged home on pod #8 in good condition.

Manufacturer Narrative

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

• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8064051
• MDR Text Key: 126951757
• Report Number: 2015691-2018-04655
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• 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: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19 YR