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

Model Number 1133

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 06/24/2015

Event Type  malfunction  

Event Description

Edwards received information that a surgeon bent the 25mm sizer in order to be inserted into the patient's aorta, and the plastic part of the handle which connects to the metal section had snapped away.A piece of plastic from the sizer's handle was dislodged onto the field.It was unknown whether the dislodged plastic piece came in contact with the patient.

Event Description

Through follow up, it was learned that the plastic section of the sizer end which connects to the metal section had snapped away.

Manufacturer Narrative

Method: device not returned.Additional manufacturer narrative: although these devices are reusable, they do not have an indefinite shelf life.According to the directions in the instructions for use (ifu) supplied with the accessories, sizers and sizer handles must be disassembled before re-sterilization.The accessories should be examined for signs of wear, such as dullness, cracking, or crazing, and do not use if deterioration is observed.In this case, the maintenance and usage information has been requested but not received.The device has not been returned for evaluation and follow up attempts to obtain the device and further information are in progress.Therefore, we are unable to confirm the clinical report or investigate further into the root cause for fracture of this device.Should new information or the complaint device is received at a later date, a supplemental mdr will be submitted.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.

Manufacturer Narrative

Through follow up, it was learned that the device is no longer available for return.Photographs were requested but the hospital confirmed that they cannot provide the photographs to edwards.

• Brand Name: CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4922136
• MDR Text Key: 6010136
• Report Number: 2015691-2015-01741
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• 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: 07/17/2015
• 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