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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER SIZER, HEART-VALVE, PROSTHESIS Back to Search Results
Model Number 113327MM
Device Problem Fracture
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.

 
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Brand NameCARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER
Type of DeviceSIZER, 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 Key6031632
Report Number2015691-2016-03062
Device Sequence Number1
Product CodeDTI
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
0 PatientS WERE Involved in the Event:
Date FDA Received10/14/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number113327MM
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/29/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2016
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

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