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

Model Number	17AHPJ-505
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, a 17mm masters mechanical heart valve was selected for implant.During procedure, as the valve was being rotated, one of the leaflets came out from the hinge mechanism.The valve was exchanged for a new non-abbott valve, which was successfully implanted.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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 leaflet.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.Please note, per the instructions for use, artmt 600080901 revision a "using the valve holder/rotator and an sjm valve holder handle, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/ rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.".

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13366623
• Report Number: 2648612-2022-00010
• Device Sequence Number: 5379353
• Product Code: LWQ
• UDI-Device Identifier: 05414734005821
• UDI-Public: 05414734005821
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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: 04/08/2026
• Device Model Number: 17AHPJ-505
• Device Catalogue Number: 17AHPJ-505
• Device Lot Number: 7922892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown