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

Model Number 1130

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: a set of model 1130 sizers were returned and evaluated by engineering.As reported, the surgeon was sizing the valve using the 25mm 1130 sizer and the barrel end slipped completely off the handle.As received, the replica ends of the 19mm, 25mm, 27mm, and 29mm sizers were detached from their rods.The barrel ends of the 23mm, 25mm, and 29mm sizers were also detached from their rods.Three broken pieces were also returned in the tray and appeared to match up to the broken areas of the 25mm and 29mm sizers.The 19mm and 27mm replica ends had broken pieces that were not returned.Cracks were observed at the rod to sizer junctions for the remaining attached replica and barrel ends of the intact sizers.Review and conclusions: based on the evaluation done by engineering, it is possible the sizers detached and fractured due to excessive wear or sterilization cycles.A capa was initiated to address the sizer fractures in the subject sizer model number.As a result of the capa, a new design to the subject model 1130 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 sizers in this event are from the design prior to implementation of the corrective action of the capa.No further action is required at this time, edwards will continue to review and monitor all events.

Event Description

It was reported via sales that the surgeon was sizing the valve using the 25mm model 1130 sizer and the barrel end slipped completely off the handle.No pieces broke off into the patient.Email from the nurse indicates, "the entire set, except for the 21mm, has cracks and the sizers have come off very easily." there was no patient injury associated with this event.

Manufacturer Narrative

Additional manufacturer narrative: report of a separated barrel end of a model 1130 sizer, which is supplied with the edwards aortic perimount magna bioprosthetic valve, model 3000/3000tfx.Per the product instructions for use (ifu), "the model 1130 sizers are supplied nonsterile and must be sterilized before using.The handles and sizers must be cleaned and resterilized prior to each use.Sizers should be examined for signs of wear, such as dullness, cracking or crazing and should be replaced if any deterioration is observed." the ifu also provided recommended sterilization conditions.The subject sizer has not been returned to edwards for evaluation, therefore the reported separated barrel end could not be confirmed or further evaluated, and the root cause cannot be conclusively determined or assigned at this time.However, it was reported that the rest of the sizers in the same set also show cracks, suggesting that replacement of the sizer set is warranted.Per the provided information and edwards review, the root cause cannot be conclusively determined; however, it is likely that this event is related to inadequate inspection of the sizers by the surgical staff prior to use.There has been no information to suggest a device quality deficiency related to this event.Edwards will continue to review and monitor all events.

• Brand Name: AORTIC MAGNA 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; ms: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 3722697
• MDR Text Key: 15288685
• Report Number: 2015691-2014-00759
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2014
• 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