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

Model Number 3300TFX21MM

Device Problems Gradient Increase (1270); Activation, Positioning or Separation Problem (2906); Insufficient Information (3190)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

Udi #: (b)(4).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.Although edwards was unable to perform device analysis, this event was most likely due to a progression of the patient¿s underlying valvular disease pathology combined with the patient¿s other underlying risk factors which included hydronephrosis of left kidney, essential hypertension, and chronic diastolic heart failure.The root cause of this event cannot be conclusively determined with the available information.However, the stenosis in this case was likely impacted by the progression of the patient¿s underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.In addition, other patient risk factors such as the patient¿s younger age at implant likely contributed to this event.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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 21mm pericardial aortic valve, implanted in the pulmonary position, underwent a valve-in-valve procedure after an implant duration of two (2) years, 11 months due to severe pulmonic stenosis.The tpvr procedure was initially attempted with a 23mm edwards transcatheter valve, but it was unsuccessful as it would not cross the pre-existing valve.A second 23mm edwards transcatheter valve was deployed successfully.The peak gradient improved from 44mmhg to 7mmhg.The patient tolerated the procedure well and was transferred to the pacu in stable condition.The patient was deemed stable to be discharge home on pod #1.

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.It is unknown whether patient and/or procedural related factors may have caused or contributed to the event.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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.

Manufacturer Narrative

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

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8106158
• MDR Text Key: 128471703
• Report Number: 2015691-2018-04888
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S042
• 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: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2019
• Device Model Number: 3300TFX21MM
• 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