MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE; ROTATABLE HEART VALVE

Model Number 27AHPJ505

Device Problems Component Missing (2306); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem Aortic Regurgitation (1716)

Event Date 05/09/2014

Event Type  Injury  

Event Description

Six hrs post-implant, severe aortic regurgitation was revealed on an echocardiogram.Reoperation was performed and the valve was discovered to be missing one leaflet.The valve was replaced and the pt was reported to be in good condition following the procedure.The dislodged leaflet remains in the pt's lower descending aorta.A procedure is scheduled.To retrieve the leaflet.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Type of Device: ROTATABLE HEART VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL; caguas PR
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 3883733
• MDR Text Key: 17576858
• Report Number: 2648612-2014-00024
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• 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
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2017
• Device Model Number: 27AHPJ505
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2012
• 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
• Patient Age: 22 YR