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

Model Number 113327MM

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

During visual examination, the barrel end was detached from the handle and had a 19mm crack that ran vertically next to the rod to junction region.Three pieces were returned that were broken off from the barrel end.A 2mmx2mm piece was identified to be missing from the barrel end and was not returned.Based on the product evaluation findings the reported condition was confirmed.Manufacturing records were unable to be reviewed as no lot number was provided.With the information received, operational context most likely contributed to this event.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards was notified that the barrel end of a 27mm sizer fractured while the surgeon was sizing the annulus of a patient.It was reported that strong force was being applied by the surgeon with a forceps.All broken pieces were recovered and the patient was not harmed.The sizer was normal in appearance; however, the sizer was not brand new.The number of uses/sterilization cycles remains unknown.The device was sterilized according to the instructions for use (ifu).

Manufacturer Narrative

Through further assessment, the device was manufactured at least 7 years prior to breaking.During product evaluation, it was identified that the barrel end of the sizer had light scratches all over.This is an indication of wear and tear overtime.Therefore, it is possible that the sizer was worn during use and the force applied contributed to the event.The complaint trend was assessed and found to be in control.Trends will continue to be monitored through the use of edwards quality systems.

• Brand Name: CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms t&d2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6031632
• MDR Text Key: 57562437
• Report Number: 2015691-2016-03062
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 113327MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2016
• 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