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

Model Number AGFN-756

Device Problems Defective Device (2588); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  malfunction  

Event Description

A mechanical valve was implanted by dr.And the atrium was closed.Once the patient's heart was restarted, it was discovered that the mechanical leaflets on the valve were faulty and would not pivot to allow blood flow.The patient's heart was re-arrested, the faulty valve was explanted and a new sjm 23mm regent mechanical valve was successfully implanted.The faulty valve was saved and returned to the manufacturer's representative.Manufacturer response for heart-valve, mechanical, sjm regent¿ (per site reporter).The representative was given the defective mechanical valve 2 weeks after explant.The response is unavailable at this time.

• Brand Name: SJM REGENT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7989984
• MDR Text Key: 124526673
• Report Number: 7989984
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: (01)05414734006095
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AGFN-756
• Device Catalogue Number: 23AGFN-756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Weight: 80