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); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2021

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 (b)(6) 2021, a 19mm regent mechanical heart valve was selected for implant.During procedure, one of the leaflets dislodged and fell into the left ventricular outflow tract (lvot) during valve rotation.All pieces of the valve were confirmed to be removed from the patient.The leaflet was reported to have been fractured.The valve was exchanged for a new 19mm regent mechanical heart valve, which was successfully implanted.The patient was reported to be in stable condition.A clinically significant prolonged procedure time of 45 minutes was reported.

Manufacturer Narrative

The reported event of a fractured leaflet could not be confirmed.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.Per a letter from the field, on the physician's second attempt to rotate the valve, "one of the leaflet of the prosthesis broke and fell into the lv cavity." while it is unclear if difficulty rotating the device contributed to the reported fracture, multiple contributory factors have been identified as potential causes.Per the instructions for use artmt600080902 rev.B, "the valve should rotate freely." "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 which also fractured was confirmed.One leaflet was fractured and dislodged from the orifice.The outflow side of the valve orifice had a small chip.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.While the root cause of the leaflet dislodgement could not be conclusively determined, there was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflets or orifice damage.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.Please note, per the regent valve instructions for use artmt600080902 version a, "valve rotation: 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.".

• 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: 11527422
• MDR Text Key: 244720637
• Report Number: 2648612-2021-00020
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 7387329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 49