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

Model Number 3300TFX21MM

Device Problems Inadequacy of Device Shape and/or Size (1583); Incomplete Coaptation (2507); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Stenosis (2263)

Event Date 05/06/2019

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.Svd, a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring 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.Patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.Ppm has been shown to be associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival.The device was not returned for evaluation, as it remained implanted.Therefore, the root cause for the stenosis and ppm remains indeterminable.However, it is likely that patient related factors and the progression of the patient¿s underlying valvular disease pathology contributed to the event.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all 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 model 3300tfx 21mm pericardial valve, implanted in pulmonary position, was disabled via a valve-in-valve procedure after an implant duration of 5 years, 5 months due to stenosis, moderate insufficiency, and patient prosthesis mismatch.A 9600tfx 23mm transcatheter valve was implanted.The patient tolerated procedure without complication.The patient was discharged in stable condition on post-operative day one.The patient was a (b)(6) male with a history of pulmonic valve endocarditis, rheumatic fever, and nonischemic cardiomyopathy.

Manufacturer Narrative

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: 8646147
• MDR Text Key: 146251319
• Report Number: 2015691-2019-01883
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2017
• Device Model Number: 3300TFX21MM
• Device Lot Number: 3715514
• 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: 44 YR