MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC MAGNA MITRAL EASE; SIZER, HEART-VALVE, PROSTHESIS

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2016

Event Type  malfunction  

Event Description

Aortic manganese 25mm sizer broke off sizer handle.All pieces retrieved.Secured in biohazard bag and returned to rep for reporting.

• Brand Name: MAGNA MITRAL EASE
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine, CA 92614
• MDR Report Key: 5636567
• MDR Text Key: 44568768
• Report Number: 5636567
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR