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

Model Number 21AGN-751

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

23 october 2019: additional information received on 21 october 2019 reported that all pieces of the device was confirmed to be removed.The patient was hemodynamically stable throughout the procedure.The user does allege a clinically significant prolonged procedure time.On (b)(6) 2019, a 21mm regent valve was selected for implant.The valve leaflet dislocated when suturing.The valve was immediately explanted and the patient was implanted with a competitor's medtronic ap360 valve.

Event Description

On (b)(6) 2019, a 21mm regent valve was selected for implant.The valve leaflet dislocated when suturing.The valve was immediately explanted and the patient was implanted with a competitor's medtronic ap360 valve.All pieces of the device was confirmed to be removed.The patient was hemodynamically stable throughout the procedure.The user does allege a clinically significant prolonged procedure time.

Manufacturer Narrative

The reported event of a leaflet dislodging and fracturing was confirmed.Gross examination revealed one leaflet had dislodged and fractured into multiple pieces.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.There was no evidence of material defect in the carbon coating that may have caused or contributed to the fractured leaflet.The cause of the reported event could not be conclusively determined, however it is consistent with damage caused by some external force applied to the leaflet which overstressed the carbon material.

• Brand Name: SJM REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9233141
• MDR Text Key: 164217458
• Report Number: 2648612-2019-00088
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: 05414734005982
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2024
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 6969666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention