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 Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/15/2018

Event Type  Injury  

Event Description

During implant of a 19mm sjm regent heart valve w/flex cuff, a leaflet dislodged during rotation using the valve holder/rotator.The device was exchanged for another 19mm regent heart valve (serial number: (b)(4)) and per report the procedure was extended by 60 minutes without further issue.There were no patient consequences reported.Additional information has been requested.

Manufacturer Narrative

The reported event of a fractured leaflet was confirmed.The returned 19mm regent heart valve was received with a fractured and dislodged leaflet.There was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet.However, the damage was consistent with some external force applied to the valve which overstressed the carbon material.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

Manufacturer Narrative

An event of leaflet dislodgement 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 artmt100122074 ver.A, "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

During implant of a 19mm sjm regent heart valve w/flex cuff, a leaflet fractured during rotation using the valve holder/rotator.All pieces of the leaflet were collected from the patient and the device was exchanged for another 19mm regent heart valve (serial number: (b)(4)).The procedure was extended by 60 minutes and the patient remained hemodynamically stable throughout.The patient was reported to be discharged.

• 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: 7724024
• MDR Text Key: 115150602
• Report Number: 2648612-2018-00057
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2021
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 5784578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 63