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); Device Dislodged or Dislocated (2923)

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

Event Date 05/18/2018

Event Type  Injury  

Event Description

A 19mm regent heart valve was selected for implant.During the procedure, a leaflet dislodged during rotation and fractured into multiple pieces.The dislodged pieces were retrieved from the patient and the valve was exchanged for another 19mm sjm regent heart valve ((b)(4)).The procedure was extended by one hour and the patient remained hemodynamically stable throughout the procedure without residual consequences.

Manufacturer Narrative

An event of leaflet fracture during rotation was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use (b)(4) 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." "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.".

Manufacturer Narrative

The reported event of a dislodged leaflet was confirmed.The reported event of the leaflet ¿fractured into multiple pieces¿ was not confirmed.One of the two leaflets had dislodged from the orifice of the returned regent heart valve.The retuned dislodged leaflet was intact and contained no anomalies.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the dislodgement remains unknown; however it is consistent with an external force applied to the leaflet and orifice, which overstressed the carbon material and resulted in the dislodgement.Please note, per the instructions for use artmt100122074 ver.A, "to avoid structural damage, the valve must be rotated in the fully closed position".

• 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: 7642998
• MDR Text Key: 112500849
• Report Number: 2648612-2018-00038
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2021
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 5477379
• Was Device Available for Evaluation?: No
• 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: 55 YR
• Patient Weight: 58