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); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information are in process.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.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 patient¿s 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.In this case, the patient underwent a concomitant cabg, switched to a smaller size valve, and expired during the procedure.Based on the information received the cause of the event cannot be determined.If additional information is received a supplemental mdr will be submitted.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported via the implant patient registry that this 23mm valve implanted in the aortic position was explanted at implant for unknown reason.Another valve of the same model but one size smaller (21mm) was implanted in replacement.As reported, this was not due to a deficiency of the original device.The patient died in surgery.No additional information was provided.

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: 9903802
• MDR Text Key: 190934184
• Report Number: 2015691-2020-11241
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: 3300TFX
• 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 Age: 78 YR