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

Model Number 1130

Device Problem Break (1069)

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

Event Date 05/31/2016

Event Type  malfunction  

Event Description

A piece of the edwards aortic valve sizer broke off as the surgeon was sizing the valve.All pieces retrieved.

• Brand Name: PERIMOUNT MAGNA
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 5881737
• MDR Text Key: 52295639
• Report Number: 5881737
• 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: 06/06/2016,08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1130
• Device Catalogue Number: 1130
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 83 YR