MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Catalog Number 27AGFN-756

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/17/2017

Event Type  malfunction  

Event Description

The surgeon was implanting the valve with 2-0 ethibond v-5 sutures, with plegets, and cor-knot.After implanting the artificial valve into the patient, the valve broke and a small piece fell into the heart.The piece was retrieved and the valve was removed.

• Brand Name: SJM REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; 177 county road b e; saint paul MN 55117
• MDR Report Key: 6375807
• MDR Text Key: 68991908
• Report Number: 6375807
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/18/2021
• Device Catalogue Number: 27AGFN-756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, CARDIO-PULMONARY BYPASS
• Patient Age: 63 YR
• Patient Weight: 98