MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER; ANNULOPLASTY RING SIZER

Model Number 1133

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the sizer is anticipated for return to edwards lifesciences and an evaluation of the product is currently pending its arrival.A supplemental report will be submitted upon completion.

Event Description

Edwards received information that during an aortic valve replacement procedure, a valve sizer broke while the surgeon was introducing the sizer into the patient's annulus.There were no reported complications for the patient as a result.

Manufacturer Narrative

Method: actual device not evaluated.Additional manufacturer narrative - although there have been attempts to retrieve the broken sizer, the product was not returned to edwards lifesciences for analysis as the hospital believes they discarded it.No additional information was provided by the hospital or surgeon to suggest that a serious injury occurred to the patient as a result of the fracture.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.

• Brand Name: CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER
• Type of Device: ANNULOPLASTY RING SIZER
• 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 ; 1 edwards way; ms: mle-8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5057175
• MDR Text Key: 25048131
• Report Number: 2015691-2015-02317
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• 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?: Yes
• Date Manufacturer Received: 08/13/2015
• 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