MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 21AGN-751

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Infarction, Cerebral (1771); Dyspnea (1816); Hemolysis (1886)

Event Date 10/15/2020

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 an unknown date a 21mm sjm regent heart valve was implanted.The patient presented with shortness of breath and hemolysis.On (b)(6) 2020, the valve was explanted and replaced with a 19mm sjm regent heart valve.During explant it was noted the one of the leaflets were not attached and dislodged.A x-ray was performed and no pieces of the leaflet were found.On (b)(6) 2020, the patient experienced a stroke.It is unknown what led to the stroke.The patient is currently being monitored and is in the icu (intensive care unit).The patient was reported to be unstable.

Manufacturer Narrative

The reported event of hemolysis and stenosis could not be confirmed.A more comprehensive assessment could not be performed as the device 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 REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 10739741
• MDR Text Key: 213177085
• Report Number: 2648612-2020-00107
• 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: 11/20/2020

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 Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 55 YR