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

Model Number 1133

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

Edwards has learned that a mitral valve sizer, model 1133, broke during use.A piece of the sizer fell into the patient¿s ventricle but was retrieved.Through follow up with the health care provider, it was learned that the sizer may have been re-sterilized too many times although the sterilization history of this device has not been made available.The surgeon indicated there was no impact to the patient.

Manufacturer Narrative

Evaluation summary: customer report of damage to the sizer was confirmed.The barrel end of the sizer was completely detached due to cracks at the overmold junction.The cracks ran along entire overmold area.A piece of plastic from the overmold junction also fell off due to cracks.The broken piece was matching with the barrel at the site of damage.There was no missing plastic fragment from the sizer.Multiple cracks were also observed at the overmold junction of the replica end.This is not a serialized device; therefore, no device history record review can be done.The maintenance history (to include cleaning and sterilization methods and parameters) has been requested but has not been made available.The surgeon did indicate that he did not know how many times the sizer had been used.If additional information is received, a follow up mdr will be submitted.The ifu was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The ifu clearly states "examine sizers and handles for signs of wear, such as dullness, cracking or crazing.Replace sizer/handle if any deterioration is observed." 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

The engineering evaluation and conclusion was completed as follows: a model 1133 sizer was returned and evaluated by engineering.As reported, a model 1133 sizer broke during use and a piece of the sizer fell into the patient¿s ventricle.The piece was retrieved and both the sizer and broken piece were returned.As received, the barrel end of the sizer was completely detached due to cracks at the overmold junction.The cracks ran along the entire overmold area.A piece of plastic from the overmold junction also fell off due to the cracks.The broken piece was matched with the barrel at the site of damage.There were no missing plastic fragments from the sizer.Multiple cracks were also observed at the overmold junction of the replica end.Based on the evaluation done by engineering, it is possible the cracks and the piece breaking off were due to excessive wear or sterilizations.Sizers are inspected at receiving inspection per procedure for distortion, cracks, and misfills.There are many variables which can affect the time it takes for cracks to form in sizers such as, but not limited to: sterilization parameters, cleaning techniques, cleaning solutions, and variability in handling during use.It is likely these cracks started to form due to age and possibly one or more of the variables mentioned.It also appears the sizer in the event is prior to corrective action.The sizers manufactured pre-capa have a clear, light yellow appearance on the barrel and replica ends while the sizers manufactured post-capa have a clear, darker yellow appearance and also have a lot number on the handle.The capa was initiated to address the sizer fractures in the magna and magna ease sizers.As a result of the capa, a new design to the 1130 and 1133 sizers was implemented.In the new design, the material was changed to provide higher temperature resistance, greater chemical resistance and greater steam sterilization stability compared to the previous material.The sizer in this event is prior to the corrective action.Fmea for this model was reviewed and the severity for the sizer breaking during use and generating fragments is critical and the occurrence is remote.In this event, the piece that dropped into the ventricle was retrieved and there did not appear to be any missing pieces during the product evaluation.Cracking and damages are expected after repeated uses.The instructions for use (ifu) state that sizers should be examined for signs of wear, such as dullness, cracking or crazing and should be replaced if any deterioration is observed prior to each use.Recommended cleaning and sterilization conditions are also included in the ifu.The above has been addressed with the customer.

• Brand Name: OBTURATOR, AORTIC 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; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; m/s lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4681854
• MDR Text Key: 5713906
• Report Number: 2015691-2015-00816
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P860057/S042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2015
• 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