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

Model Number 116123MM

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2018

Event Type  malfunction  

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.As per the reported information, it was believed that the device had gone through at least 150 sterilization cycles.The product instructions for use (ifu) list time and temperature guidelines as well as equipment and solution recommendations for by hand and by machine cleaning and sterilization.Included in the ifu is the following statement: "caution: examine sizers and handles for signs of wear, such as dullness, cracking or crazing.Replace sizer/handle if any deterioration is observed." this inspection is done prior to cleaning and sterilization and should prevent breakages during use.The sizer has not been returned at this time.Therefore, the event is unable to be confirmed at this time.The root cause of the event remains indeterminable.A supplemental report will be submitted if new information is received.

Event Description

Edwards received notification that during the sizing of the annulus in the avr replacement procedure, the surgeon noticed a piece of the body of the 23mm sizer had broken off.As reported, normal force was applied in this case.The surgeon located the fragment in the lv and retrieved it.The patient was noted as to be hospitalized in stable condition after the procedure.As per theatre staff opinion, the device has gone through at least 150 sterilization cycles.The device was available for return and evaluation.

Manufacturer Narrative

Customer report of "piece of the body of the sizer model 116123mm had broken off" was confirmed.Total of 6 sizers were returned:19mm, 21mm, 23mm, 25mm, 27mm, and, 29mm.All six sizers appeared scratched and frosted-like.The 23mm sizer had two cracks that measured 12mm(a), and 10mm(b).In addition, the 23mm sizer was broken at two locations which measured approximately 14mmx2.5mm(c) and 8mmx2mm(d).Broken fragments were not returned.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.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

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER
• Type of Device: SIZER, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7691606
• MDR Text Key: 114558833
• Report Number: 2015691-2018-02846
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 116123MM
• Device Lot Number: 47378
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR