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

Model Number 23AGFN-756

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event that the valve leaflets were "broken" could not be confirmed.The results of the investigation are inconclusive, as the device was not returned for analysis; however, 5 photos provided from the field displayed a partially dislodged leaflet that remained within the orifice.No other damage was noted on the orifice.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.With the evidence provided, no material defect in the carbon coating could be ascertained that may have caused or contributed to the displaced leaflet.Rather, these may have been caused by some external force applied to the valve which overstressed the carbon material please note, per the instructions for use artmt600080902 ver.A, "use only the valve holder/rotator packaged with the sjm regent¿ mechanical heart valve to perform valve rotation.Use of other instruments could result in structural damage.The valve holder/rotator is intended for single use only and should be discarded after surgery." "to avoid structural damage, the valve must be rotated in the fully closed position." "to minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve".

Event Description

On (b)(6) 2020, a 23mm sjm regent heart valve w/flex cuff was selected for implant.During the procedure, the valve leaflets were broken during the implant while the surgeon tried to rotate the valve using the valve rotator recommended in the ifu.All pieces of the leaflet were removed from the patient and a new 23mm sjm regent heart valve w/flex cuff was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was a clinically significant 20 minute delay in the procedure.

• 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 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9795226
• MDR Text Key: 191606778
• Report Number: 2648612-2020-00021
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (y/n): N
• Reporter Country Code: WE
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/05/2020

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
• Device Expiration Date: 03/18/2023
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 6368630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 84