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

Model Number 19AGFN-756

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Human-Device Interface Problem (2949)

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

Event Date 05/10/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2021, a 19mm sjm regent heart valve w/flex cuff was selected for implant.During procedure, at the time of implant, an attempt was made to rotate the valve, however "it was locked, which is why several attempts were made to rotate it and it fractured in one portion of the ring." the leaflets were not fractured; all pieces of the valve were confirmed to have been removed from the patient.The physician reported patient anatomy interference.The valve was exchanged and a new 19mm sjm regent heart valve w/flex cuff was successfully implanted.It was reported that the patient was not hemodynamically stable throughout the procedure and there was a clinically significant prolonged procedure time.No patient consequences were reported post-procedure.Additional information received on 21 may 2021 reported that on (b)(6) 2021, the patient passed away due to ventricular dysfunction due to prolonged pumping time.

Manufacturer Narrative

Additional information sections: h6, h10 an event of the valve being "locked" while attempting to rotate it, valve fracture, and patient death was reported.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.Please note, per the regent valve instructions for use, artmt600080902 revision b "warnings: never apply force to the valve leaflets.Force may cause structural damage to the valve.".

Manufacturer Narrative

The reported event of a fractured orifice was confirmed.The orifice was fractured near the pivot guard and the bottom orifice was also chipped.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the root cause of the orifice fracture could not be conclusively determined, the damage may have been caused by some external force applied to the valve which overstressed the carbon material.Please note, per the regent valve instructions for use, artmt600080902 revision b "valve rotation: using the valve holder/rotator and the flexible valve holder handle model 905-hh, or the rigid valve holder handle model 905-rhh, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.".

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• 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: 11894514
• MDR Text Key: 252951130
• Report Number: 2648612-2021-00056
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• 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,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 7733507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death