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

Model Number 1173R

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Attempts to retrieve the device and additional information is in process.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received notification that during use, a magna ease mitral sizer model 1173r31 broke and pieces fell into the patient.As reported, the issue occurred while the surgeon was using the device on the patient mitral ring.The surgeon had to retrieve two pieces that had remained in the heart.

Manufacturer Narrative

Customer report of broken sizer was confirmed.As received, the barrel end of the sizer (lot# e1611168) had broken off at rod to sizer junction.Cross surfaces of the broken barrel end area were uneven.Broken off fragments of barrel end matched up.

Manufacturer Narrative

Updated: b5, g3.

Event Description

Edwards received notification that during use, this magna ease mitral sizer model 1173r31 used before broke and pieces fell into the patient (all the pieces were found).As reported, the issue occurred while the surgeon was using the device on the patient mitral ring.The surgeon had to retrieve two pieces that had remained in the heart.As reported patient was notice as to be doing well.

Manufacturer Narrative

Corrected data h6 (device code(s)).Updated section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).Dhr review was performed and no relevant non-conformances were identified.A lot history review revealed no other similar issues for the reported lot.Current risk mitigations include material specifications and inspections, cleaning and sterilization instructions, and ifu warnings and cautions.Handles and sizers are re-usable instruments that are re-sterilized after each use.They are often used until visible damage is detected.They are typically inspected by the operative team during cleaning and prior to packaging for re-sterilization and fractures can be visually detected.Based on the information available, a definitive root cause cannot be conclusively determined, however, based on the date of receiving inspection, it is likely that the fragmentation is due to wear and tear.An edwards defect has not been confirmed.

• Brand Name: EDWARDS HEART VALVE SIZER
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16020682
• MDR Text Key: 305873464
• Report Number: 2015691-2022-10195
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1173R
• Device Lot Number: E1611168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening