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

Model Number 1130

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The valve sizer was not returned to edwards for analysis as it is not the hospital's practice to return.However, pictures were provided of the broken sizer and an evaluation of the images is currently pending.A supplemental report will be submitted upon completion.

Event Description

Edwards received information that during the procedure, this 21mm aortic valve sizer broke.As reported, the surgeon was sizing the valve when the sizer fractured.All pieces were retrieved and there were no reported complications/adverse events to the patient as a result.The sizer is sterilized using steam and it is unknown how long the sizer had been in use.

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.However, the customer provided 8 color images of the broken sizer; size 21mm.5 images of the sizer at different angles, 2 images of the sizer with the fragment, and 1 close up image of the fragment.The barrel end of the sizer was broken at the rod to sizer junction region; one fragment was broke off.Images of the sizer handle were not provided.Additional manufacturer narrative: the customer report of sizer broke off was confirmed through image evaluation.Handles or sizers that fragment when in use within the operative field have the potential to result in a piece being retained in the heart that could then embolize when the patient¿s heart begins beating.This has the potential to cause a stroke or myocardial infarction.In this case, all the pieces were able to be recovered and no adverse effects to the patient.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 resterilization.The accessories should be examined for signs of wear, such as dullness, cracking, or crazing, and do not use if deterioration is observed.It is unknown in this case how long the sizer had been in use.There is no serial number or lot number available for this device; therefore, the device history record (dhr) review cannot be done.No corrective action is applicable to this case; however, 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.No corrective or preventative actions are required.

• 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: t&d 2nd floor, office t223; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5987781
• MDR Text Key: 55945772
• Report Number: 2015691-2016-02883
• 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,other,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• 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
• Patient Sequence Number: 1
• Patient Age: 83 YR