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 Aortic Valve Stenosis (1717)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

The reason for admission: severe aortic stenosis.In the operation of aortic valve replacement, 19agfn-756 (serial number: (b)(4)) was used, the valve leaves were detached, and another valve were used to complete the operation.(china cc called the tsr and was told that a 21agfn-756 was used to complete the procedure).

Event Description

On (b)(6) 2020 patient was admitted with severe aortic stenosis.Patient underwent an aortic valve replacement.The physician implanted a sjm regent heart valve w/flexcuff (19agfn-756, serial number (b)(6)).The leaves of the valve were detached and another valve was used to completed the operation (21agfn756).The patient is recovering.

Manufacturer Narrative

The reported event of a dislodged leaflet was confirmed.Both leaflets were dislodged from the orifice and only one returned with the valve.A small chip was also noted in one pivot guard.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.

• 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 ; RQ 00725
• MDR Report Key: 10170123
• MDR Text Key: 196434439
• Report Number: 2648612-2020-00066
• 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
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: 7352858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR