MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Model Number	21AHPJ-505
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
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 21mm masters series hemodynamic plus valve was selected for implant in the patient.One of the leaflets broke into 3 pieces after suturing the valve in place.All pieces of the broken leaflet and the valve was removed from the patient and exchanged for a 19mm masters series hemodynamic plus valve.The physician does not attribute this event to oversizing, there was no other set and valve available and time was running out.The 19mm masters series hemodynamic plus valve was successfully implanted.There was a 20-30 minute clinically significant delay in the procedure, but the patient remained hemodynamically stable throughout the procedure and experienced no serious injuries.
Additional Manufacturer Narrative
The reported event of a fractured leaflet was confirmed.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: SJM MASTERS SERIES HEMODYNAMIC PLUS 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: 10712439
• Report Number: 2648612-2020-00104
• Device Sequence Number: 16958706
• Product Code: LWQ
• UDI-Device Identifier: 05414734006002
• UDI-Public: 05414734006002
• 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: 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
• Report Date (Section B): 02/17/2021

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: 08/05/2024
• Device Model Number: 21AHPJ-505
• Device Catalogue Number: 21AHPJ-505
• Device Lot Number: 7123118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1