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

Device Problem Biocompatibility (2886)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2002, a 23mm sjm hp regent aortic valve was implanted.In (b)(6) 2019, valve thrombosis was reported due to anticoagulation pause for bladder problems with insufficient bridging; the patient was treated with thrombolysis.In (b)(6) 2019, new valve thrombosis was reported.On (b)(6) 2019, redo operation was performed and the regent valve was explanted.A competitor's ce perimount magna ease 21 was successfully implanted.No patient consequences were reported.

Manufacturer Narrative

The reported event of thrombus was confirmed.The investigation found that there was limited mobility of one of the mechanical leaflets and that thrombus was present in one of the recessed pivot areas.No acute inflammation was present.The cause of the reported event could not be conclusively determined, however information from the field indicated that the patient was known to have difficulties with inr values.

• Brand Name: REGENT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9793350
• MDR Text Key: 182186402
• Report Number: 2648612-2020-00013
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR