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

Model Number 19AGN-751

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 19mm regent was selected for implant.Upon implantation, one of the leaflets dislodged and migrated to the inside of the left ventricle.The patient is reported stable, but the event impacted the surgery.Additional information has been requested.

Manufacturer Narrative

The reported event of a dislodged leaflet was confirmed.On leaflet was dislodged from the orifice and returned with the valve.No other damage was noted.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.The cause of the leaflet dislodgment could not be conclusively determined.Please note, per the instructions for use artmt100122074 ver.A, "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.".

Event Description

On (b)(6) 2018, a 19mm regent valve was selected for implant.Upon implantation and rotation with the holder, one of the leaflets dislodged and migrated to the inside of the left ventricle.The leaflet was retrieved and another 19mm regent valve was implanted (serial number: unknown).The patient is reported stable; however, the event impacted the surgery due to delay, resulting in hemodynamic compromise.

• Brand Name: SJM REGENT HEART VALVE
• 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: 8243923
• MDR Text Key: 132926385
• Report Number: 2648612-2019-00007
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: 05414734005869
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2023
• Device Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: 6390572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention