MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CS-LILLEHEI) SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS; HEART-VALVE, MECHANICAL

Model Number CDR-2048

Device Problem Biocompatibility (2886)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/18/2004

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2004 a 15 mm sjm mechanical heart valve hemodynamic plus was implanted.On (b)(6) 2004 the asymptomatic patient was treated with heparin an anticoagulant for valve thrombosis.Additional information has been requested.

Manufacturer Narrative

Additional information: g3, g6, h2, h6, h10.An event of thrombus was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CS-LILLEHEI); one lillehei plaza; st. paul MN 55117
• MDR Report Key: 11521588
• MDR Text Key: 240933536
• Report Number: 2126673-2021-00001
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2009
• Device Model Number: CDR-2048
• Device Lot Number: 0002650233
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 MO
• Patient Weight: 4