MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM REGENT HEART VALVE W/FLEX CUFF

Model Number 21AGFN-756

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/21/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated a pt underwent aortic valve replacement with a 21mm sjm regent valve (model: 21agfn-756, serial: (b)(4)) on (b)(6) 2014.The annulus was sized using a sjm 905 sizer.The valve was placed in the supra-annular position using non-everting mattress sutures.Forceps were used to rotate the valve after it was detached from the valve holder.After applying force to rotate the valve, one leaflet fractured and the other leaflet was dislodged.A fragment of the broken leaflet was not recovered.The valve was explanted and replaced with a 19mm sjm regent valve (model: 19agfn-756, serial: (b)(4)).The physician states the event was not due to the device and the pt is in stable condition.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Manufacturer (Section D): ST. JUDE MEDICAL; cagus PR
• Manufacturer Contact: denise johnson, rn ; p.o. box 998; lot 20 b st; caguas, PR 00725 ; 6517564470
• MDR Report Key: 3677118
• MDR Text Key: 4303558
• Report Number: 2648612-2014-00011
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002/S057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2013
• Device Model Number: 21AGFN-756
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2018
• Is the Device Single Use?: Yes
• 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