MAUDE Adverse Event Report: EDWARDS LIFESCIENCES BARREL SIZER SET, MAGNA MITRAL; SIZER, HEART-VALVE, PROSTHESIS

Model Number SET1173B

Device Problem Fracture (1260)

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

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional narratives.Harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.The device was not returned for evaluation, as device request is still ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

It was reported that the sizer broke inside of the heart during a mitral valve repair procedure using a 4450 32mm mitral ring.The sizer broke while in use.Surgical team notified immediately.All broken pieces were removed from the patient and another set of sizers was opened for comparison purposes.Broken sizer was discontinued from use.No harm occurred to the patient.Per medical records the patient presented with severe mr.The patient underwent mv repair and laa ligation.Post-op tee revealed trivial mr with excellent coaptation of the leaflets.The patient condition was stable and he was discharged on pod #5.

Manufacturer Narrative

H10: additional narratives.Updated h6.Based on the information available, the complaint is able to be confirmed however, a definitive root cause cannot be conclusively determined.An edwards defect has not been confirmed.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.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.

• Brand Name: BARREL SIZER SET, MAGNA MITRAL
• 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18436884
• MDR Text Key: 331864235
• Report Number: 2015691-2024-00025
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SET1173B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male