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

Model Number	21AGN-751
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9233141
• Report Number: 2648612-2019-00088
• Device Sequence Number: 2524679
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: 05414734005982
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/09/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention