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

Model Number 6900PTFX29

Device Problems Inflation Problem (1310); Failure to Align (2522); Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problems Mitral Valve Stenosis (1965); No Code Available (3191)

Event Date 11/21/2018

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) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards 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

It was reported that this patient with a 29mm pericardial mitral valve underwent a valve-in-valve procedure after an implant duration of 10 years, six (6) months due to mitral stenosis.The tmvr procedure was first attempted with a 29mm edwards transcatheter valve system with the nose cone across the atrial septum into the left atrium, but the valve would not align after many attempts, including bringing the system into the ivc, causing the balloon to ¿bunch¿ up, making an implant/deployment too precarious.The system removed.Another 29mm edwards transcatheter valve system was prepped and inserted into the left atrium with nose cone.There was also much difficulty aligning the valve on the balloon and it took multiple fine alignment resets to get the transcatheter valve between the markers.The valve crossed the pre-existing bioprosthetic valve with some difficulty.When deployment was attempted, the balloon failed to inflate, suggesting obvious compromised balloon integrity.The second system was removed as a unit similar to the first system.The third transcatheter valve system was inserted without difficulty into the femoral vein, and a third 29mm edwards transcatheter valve system was prepped.The third system was inserted through the esheath with alignment done in the ivc/right atrium without difficulty.The system crossed the septum and pre-existing valve with some difficulty.The 29mm edwards transcatheter valve was deployed successfully.The patient was ultimately transferred to the outpatient area extubated and in stable condition.

Manufacturer Narrative

Event Description

It was reported that a patient with a 29mm pericardial mitral valve underwent a valve-in-valve procedure after an implant duration of 10 years, six (6) months due to mitral stenosis.Per the medical records, two attempts for tmvr were made with a size 29mm edwards transcatheter vale placed through two different sheaths to cross the septum; however, during the manipulation process, it was felt that the mounting of the balloon within the valve was not going successfully.Also, at one point, even though the transcatheter valve crossed the pre-existing mitral valve, the surgeon was unable to inflate the balloon properly, which it was felt that because there was no inflation of the balloon at all and the stent was not deployable, the whole apparatus was pulled out and the sheath was replaced for a third time.The third attempt to deploy a 29mm edwards transcatheter valve was successful.It was also noted that closure of the atrial septal defect was performed with complete occlusion.The patient remained hemodynamically stable throughout the procedure and tolerated the procedure well.The patient's post operative course was complicated by pseudoaneurysm.The patient was discharged home on pod #6.

Manufacturer Narrative

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

• 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: 8146698
• MDR Text Key: 129790059
• Report Number: 2015691-2018-05166
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2009
• Device Model Number: 6900PTFX29
• 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: 78 YR