MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. MASTERS SERIES CAVGJ,AUS TRALIAN,27MM; HEART-VALVE, MECHANICAL

Model Number	27CAVGJ-514 00
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2020
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) 2020, a 27mm masters series cavg was selected for implant in the patient.During device implantation, the valve leaflets snapped.The physician used the valve rotator recommended in the ifu, but resistance was felt and one leaflet was intact and the other shattered as it fell into the left ventricle.All pieces of the dislodged leaflet and fractured pieces were removed from the patient and the patient did not experience any serious injuries.The valve was replaced with a 25mm masters series cavg and the patient remained hemodynamically stable throughout the procedure.An increased bypass time was reported.The patient is currently stable and discharged.
Additional Manufacturer Narrative
The reported event of a dislodged and fractured leaflet was confirmed.Both leaflets were dislodged from the orifice and one leaflet was also fractured.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 and there was no evidence of orifice damage.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.Please note, per the masters series cavgj valve instructions for use, arten100046405 revision a."warnings: proper valve size selection is crucial.Do not oversize the valve.Use a smaller size sjm masters series aortic valved graft if the patient annulus measurement falls between two sjm masters series aortic valved graft sizes.Use only st.Jude medical¿ mechanical heart valve sizers." "warnings: never apply force to the valve leaflets.Force may cause structural damage to the valve.".
Additional Manufacturer Narrative
The reported event of a dislodged and fractured leaflet was confirmed.Both leaflets were dislodged from the orifice and one leaflet was also fractured.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 or orifice damage.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.

• Brand Name: MASTERS SERIES CAVGJ,AUS TRALIAN,27MM
• 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: 10864525
• Report Number: 2648612-2020-00119
• Device Sequence Number: 11478881
• Product Code: LWQ
• UDI-Device Identifier: 05414734006422
• UDI-Public: 05414734006422
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2024
• Device Model Number: 27CAVGJ-514 00
• Device Catalogue Number: 27CAVGJ-514 00
• Device Lot Number: 7315864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/13/2021; 01/29/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/14/2021; 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1