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

Model Number 21AGFN-756

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On an unknown date, a 21 mm regent heart valve w/flex cuff was selected for implant.Post-deployment, one of the leaflets failed to move.The physician attempted to rotate the valve with the valve holder, but the leaflet dislodged.The leaflet was recovered, and the valve explanted.A replacement 19 mm regent heart valve w/flex cuff was successfully implanted.The event led to a significant extension in the procedure time, but the patient was reported to be stable.

Manufacturer Narrative

An event of one of the leaflets not moving and the leaflet dislodging while the valve was rotated was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use artmt100078770 revision a "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".

Event Description

On (b)(6) 2020, a 21mm regent heart valve w/flex cuff was selected for implant.Post-deployment, one of the leaflets failed to move.The physician attempted to rotate the valve with the valve holder, but the leaflet dislodged.The leaflet was recovered, and the valve explanted.A replacement 19mm regent heart valve w/flex cuff was successfully implanted.The event led to a significant extension in the procedure time, but the patient was reported to be stable.

Manufacturer Narrative

The reported event of a dislodged leaflet was confirmed.One leaflet was dislodged from the orifice and returned with the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the leaflet dislodgment could not be conclusively determined.Please note, per the instructions for use artmt100078770 revision a "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".

• 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: 10277473
• MDR Text Key: 198926991
• Report Number: 2648612-2020-00076
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• 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,Followup
• Report Date: 11/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2023
• Device Model Number: 21AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: 6418080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention