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

Model Number	19AGN-751
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2021, a female patient was admitted to the hospital with severe mitral stenosis(ms), severe rheumatic heart disease(rhd) and severe aortic stenosis(as).The patient was posted for a double valve replacement(dvr) and tva.A 19mm regent heart valve (sn: (b)(4)) was selected for implant in the patient's native aortic valve.During the procedure the leaflet of the valve broke during placement of the sutures all pieces of the fractured leaflet were recovered and the valve was replaced with a competitor's valve.The patient did not experience any serious injuries and the patient remained hemodynamically stable throughout the procedure.There was a 30 minute delay in the procedure included bypass time.The patient is currently stable.
Additional Manufacturer Narrative
Additional information for: g3, g6, h2, h6, and h10 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.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet was confirmed.One leaflet was fractured and 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
• Common Device Name: 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: 11376270
• Report Number: 2648612-2021-00014
• Device Sequence Number: 11771579
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: 05414734005869
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2024
• Device Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: 7311904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 09/27/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 05/28/2021; 09/29/2021
• 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
• Patient Age: 38 YR