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

Model Number 3300TFX

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

Additional narratives: 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 was discarded.The root cause of this event cannot be conclusively determined.However, it is likely that patient related and/or procedural factors contributed to the event.

Event Description

It was learned via implant patient registry that a 21mm aortic valve was explanted and replaced with a 29mm valve after an implant duration of 4 years, 4 months due to patient prosthesis mismatch, severe stenosis, and moderate to severe regurgitation.Per medical records the patient presented with chf and underwent redo-avr and rectangular root enlargement with hemashield patch.Intra-op tee showed normal functioning bioprosthesis with no paravalvular leak.Post-op course was complicated by seizure-like activity and hypernatremia.Patient was discharged to sar on pod #21.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.

Event Description

It was learned via implant patient registry that a 21mm aortic valve was explanted and replaced with a 29mm valve after an implant duration of 4 years, 4 months due to patient prosthesis mismatch, severe stenosis, and moderate to severe regurgitation.Per medical records the patient presented with chf and underwent redo-avr and rectangular root enlargement with hemashield patch.Intra-op tee showed normal functioning bioprosthesis with no paravalvular leak.It is noted the 21mm aortic valve had 2 holes in the non-coronary cusp.Post-op course was complicated by seizure-like activity and hypernatremia.Patient was discharged to sar on pod #21.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.

Manufacturer Narrative

The device history record (dhr) was not reviewed as 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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 11726816
• MDR Text Key: 252261943
• Report Number: 2015691-2021-02685
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S04
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR