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

Model Number 1133

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

Additional information received indicates the reported sizer was discarded.The patient tolerated the procedure well with no reported complications.

Event Description

Edwards learned of a sizer that broke off into several pieces as the surgeon was sizing and pulled the sizer from the annulus.There were no reported complications or injury to the patient.Attempts to obtain additional information and explanted device have been unsuccessful.

Manufacturer Narrative

Additional manufacturer narrative - the reported device was not returned to manufacturer.Without receipt of the explanted device the reported clinical observation cannot be confirmed.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.

• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; one edwards way; ms: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4842117
• MDR Text Key: 6193478
• Report Number: 2015691-2015-01390
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1