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 Fracture (1260)

Patient Problems Ventricular Fibrillation (2130); Foreign Body In Patient (2687); Respiratory Insufficiency (4462)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2021, a 19 mm st.Jude medical (sjm) regent heart valve with flex cuff was chosen for procedure.During the procedure once the valve was implanted, both of the leaflets on the valve dislodged while the valve was being rotated.When the valve was being rotated, the valve was in the closed position and the holder handle was fully inserted into the orifice at a 90-degree angle.There was no resistance felt during valve rotation.It appeared that the insertion edges of both leaflets fractured.Both leaflets were recovered from the patient, but the insertion edges were unable to be recovered.The patient remained hemodynamically stable throughout the procedure, but this event caused a clinically significant delay in procedure.In the first 24 hours after procedure, the patient had 5 ventricular fibrillation events, two of which required electric treatment and one of which required cardiopulmonary resuscitation (cpr).Following these events, the patient status was reported to be stable.The patient did not experience any permanent injury or damage as a result of this event.No additional information was available.

Manufacturer Narrative

Additional information: g3, h2, h3, h6, h10.The reported event of a dislodged leaflets was confirmed.The pivot guard was fractured and both the leaflets were dislodged from the orifice.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.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.

• 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: 12492035
• MDR Text Key: 272025753
• Report Number: 2648612-2021-00091
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 7892652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention