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

Model Number 1130

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: 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.In this case, it is unknown how long the sizer had been in use.The device return is in progress.Without the return of the device, the root cause remains indeterminable.If new information is received, a supplemental report will be submitted.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.

Event Description

Edwards received information that a 29 mm sizer broke while handling it to size an aortic valve.There was no injury to the patient as a result of the broken sizer and all the pieces were retrieved.It is unknown how long this sizer had been in use.Per the customer, there is no lot number visible on the handle.

Manufacturer Narrative

Evaluation summary: as received, the barrel end was detached from the handle.The barrel end had a 8 mm x 10 mm piece that broke off at the rod to sizer junction region.The broken piece matched up to the barrel.The replica end had multiple crazing and two 13 mm cracks that ran vertically next to the rod to sizer junction region.There did not appear to be any missing pieces.Engineering task will be opened for further evaluation.Product appeared in the same condition as in the image provided by the customer.Customer report of broken sizer was confirmed.The root cause of the event remains indeterminable.However, the age of the sizer may have contributed to the event.

• 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 ; one edwards way; m/s mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6091458
• MDR Text Key: 59580724
• Report Number: 2015691-2016-03330
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• 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: 49 YR