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

Model Number 21AGFN-76

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/09/2015

Event Type  Injury  

Event Description

Mechanical aortic valve 21 mm 21agfn-756 sn (b)(4) was seated at 1030.While seating it, one of the carbon leaflets broke off.Endoscopic equipment was opened to check for possible valve debris.Heart was flushed multiple times; however, debris may have been retained.

• Brand Name: ST JUDE MEDICAL
• Type of Device: MECHANICAL HEART VALVE SJM REGENT
• Manufacturer (Section D): ST JUDE MEDICAL; 177 county rd; st paul MN 56117
• MDR Report Key: 5124181
• MDR Text Key: 27420897
• Report Number: MW5056770
• Device Sequence Number: 1
• Product Code: LWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2018
• Device Model Number: 21AGFN-76
• Other Device ID Number: 05414734005975
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 77