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

Model Number 19AGN-751

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturer report number: 2648612-2021-00055.On (b)(6) 2021, a 19mm sjm regent heart valve was selected for implant.While the device was fitted into the aorta and sutures were placed, the device leaflets became fractured.The device was removed with all fractured leaflet pieces and a new 19mm sjm regent heart valve was selected.While the replacement device was being rotated, the valves leaflet became dislodged.The device and leaflet were removed and successfully replaced with another 19mm sjm regent heart valve to resolve the event.The patient remained hemodynamically stable throughout the procedure however, the procedure extended longer than what is clinically acceptable.The patient is stable.

Manufacturer Narrative

The reported event of a dislodged leaflet was confirmed.One leaflet was dislodged from the orifice and returned with the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the leaflet dislodgment 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: 11891205
• MDR Text Key: 252900663
• Report Number: 2648612-2021-00054
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: 05414734005869
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: 7462523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization