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

Model Number 3300TFX

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative the event is reported as a valve explant at implant.This is typically a result of inappropriate sizing, distortion of the valve during implantation and or the patients anatomy, and not a malfunction of the device.There may be cases in which regurgitation is detected by tee prior to the completion of the surgical case and exchange of the valve is required.Explant of one valve and implant of another valve may result in complications.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

Edwards received notification that a 23mm aortic valve was explanted at implant due to aortic injury occurred after valve deployment.As reported, the patient's annulus was heavily calcified and there was suspicion of valve oversizing.After an annular repair a 21mm valve was implanted in replacement.

Event Description

Edwards received notification that a 23mm aortic valve was explanted at implant due to aortic perforation occurred after valve deployment.As reported, the patient's annulus was heavily calcified and there was suspicion of valve oversizing.After an annular repair a 21mm valve was implanted in replacement.Per medical opinion, the aortic injury was not related to the edwards device.The patient did not suffer any injury or adverse event due to the explant at implant and was noted as to be in good health condition.

Manufacturer Narrative

H10: additional narratives.Updated b5 per new information received.

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: 11473141
• MDR Text Key: 239419973
• Report Number: 2015691-2021-01830
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 87 YR