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

Model Number 3300TFX

Device Problems Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: udi (b)(4).The device was not returned to edwards for evaluation as it remains implanted.The device history record (dhr) was reviewed, and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.A manufacturing related issue was not identified.A definitive root cause could not be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a patient with a 19mm valve implanted for three years, four months was scheduled for a valve-in-valve procedure due to severe aortic stenosis associated with patient prosthesis mismatch.

Manufacturer Narrative

H10.Updated b5.

Event Description

It was reported that a patient with a 19mm valve implanted for three years, five months underwent a valve-in-valve procedure due to severe aortic stenosis associated with patient prosthesis mismatch.A 20mm valve was implanted.The patient was doing well.

Event Description

It was reported that a patient with a 19mm valve implanted for three years, five months underwent a valve-in-valve procedure due to severe aortic stenosis associated with patient prosthesis mismatch.A 20mm valve was implanted.The patient was discharged home on pod #1.

Manufacturer Narrative

H10.Updated section b5.

• 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: 10639342
• MDR Text Key: 210203372
• Report Number: 2015691-2020-13862
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2021
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 54