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

Model Number 1133

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: as received, the barrel end of the sizer was completely detached from the rod.The barrel end had two pieces broken, both were 10mm in length.The pieces matched up to the barrel, and there did not appear to be any missing pieces.The replica end had 3 crazes seen at the rod to sizer junction.Additional manufacturer narrative: customer report of broken sizer was confirmed.There is no serial number of lot number available for this device; therefore, the device history record (dhr) review cannot be done.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.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.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 25mm sizer broke inside the patient during use.All the pieces were able to be recovered and there was no patient injury related to the broken sizer.The patient outcome was reported as, "fine." the broken sizer was returned for evaluation.No additional information was provided.

Manufacturer Narrative

Additional information was obtained through follow up with the healthcare provider.(b)(4).Additional comments were provide by engineering.The root cause of cracking/crazing on the barrel end of the sizer was likely due to the age of the device at the time of use.The device was approximately (b)(6) years old at the time that it broke.It is unknown how many operations the device had been used in, but there are a large amount of visible scratches and indications of heavy wear on both the replica and sizing end.

Event Description

Through follow-up with the health care provider, it was learned that a 27mm pericardial valve was implanted and echocardiographic examination revealed a well seated prosthesis with no evidence of paravalvular leak and appropriate leaflet function.The patient was discharged to a rehab facility on post-operative day seven (7).It was also reported by the sterile processing department at the hospital that the broken sizer was steam sterilized per the instructions for use (ifu).

• 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; mle-8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5551891
• MDR Text Key: 42000819
• Report Number: 2015691-2016-01110
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• 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: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2016
• 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: 77 YR