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 Obstruction of Flow (2423); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a double valve replacement was performed in a patient with severe native aortic stenosis and moderate native rheumatic mitral stenosis.A 25mm masters expanded cuff valve (serial number: (b)(4)) was implanted without issue in the mitral position, and an atriclip 35 closed the laa.A 19mm regent mechanical heart valve (serial number: (b)(4)) was selected for implant in the aortic position.After the user decalcified the annulus and removed the native aortic cusps, the 19mm valve did not fit.The user performed a hegar-based technique to enlarge the annulus, with 19, 20, and 21mm dilators.The physician removed the 21mm hegar dilator, and easily implanted the 19mm regent valve.While checking leaflet movement, the user observed the leaflets were obstructed due to the plagettes.The user attempted to rotate the valve using the valve holder, and during rotation, the leaflets dislodged.Both leaflets were retrieved from the patient.The user exchanged the 19mm regent valve for a 19mm carbomedics sorin valve that was implanted successfully.The user reported the procedure was significantly extended due to the exchange and the patient remained hemodynamically stable throughout.There were no issues with the 25mm masters valve in the mitral position.Post-operatively, the patient is reported to be stable.

Manufacturer Narrative

The reported event of leaflet dislodgement was confirmed.Both leaflets of the returned regent heart valve were dislodged from within the orifice.There was no evidence of material defect that may have caused or contributed to the dislodged leaflet.Rather, the leaflet dislodgement was consistent with some external force applied to the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the leaflet dislodgement during the procedure remains unknown, however per the instructions for use (ifu), 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: 8024575
• MDR Text Key: 125667319
• Report Number: 2648612-2018-00090
• 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
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2023
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 6513872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 62