MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART VALVE

Device Problems Degraded (1153); Activation, Positioning or Separation Problem (2906)

Patient Problems Aortic Valve Stenosis (1717); Failure of Implant (1924)

Event Date 11/07/2016

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.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 structural valve deterioration.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.However, the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.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

Edwards reviewed the article "transcatheter aortic valve-in-valve implantation using lotus valve for failed surgical bioprostheses" author roberto nerla et al.It was reported that this patient with a 23mm edwards surgical valve, implanted in the aortic position, underwent a valve-in-valve procedure after an implant duration of approximately 15 years due to degeneration leading to aortic stenosis.The tavr was performed with a 23mm non-edwards transcatheter valve, but it was not successful due to a restrictive valve-root mismatch.The valve did not deploy satisfactory and the final decision was made to retrieve the transcatheter valve and perform a redo surgery.The patient received a non-edwards mechanical prosthesis, and her clinical follow-up was uneventful.

Manufacturer Narrative

Reference capa-20-00141.

• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7742099
• MDR Text Key: 115786143
• Report Number: 2015691-2018-03118
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• 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: 32 YR