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

Model Number 2800

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Regurgitation (2259); Stenosis (2263)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: 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 remains implanted.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.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.

Event Description

It was reported that a 23mm aortic valve was disabled via a valve-in-valve procedure after an implant duration of 16 years, 8 months due to stenosis and severe regurgitation secondary to patient-prosthesis mismatch.A 23mm transcatheter valve was implanted.Patient was discharged home on pod #1.Per medical records, the severe aortic prosthetic regurgitation with elevated gradients was noted after an approximate implant duration of 9 years.As reported, the surgical valve performed as intended.

Manufacturer Narrative

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

Manufacturer Narrative

H10: additional manufacturer narrative.Updated h6: per new information received.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10292406
• MDR Text Key: 200649265
• Report Number: 2015691-2020-12580
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S001
• 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: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2800
• 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: 73 YR