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

Model Number	27MECJ-502
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a mitral valve replacement procedure, a 27 mm masters series mitral valve was attempted to be rotated with the sjm holder and one leaflet dislodged from the butterfly hinge and got stuck within the housing of the valve.The valve was explanted and replaced with a smaller 25 mm masters series mitral valve.Cpb time was extended for 30 minutes due to this event; however, the patient is reported to be stable.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet was confirmed.One leaflet was dislodged intact from the orifice.The sewing cuff contained a small tear, roughly where the retention suture would have secured the valve to the holder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the leaflet dislodgment remains unknown; however, information from the field indicated that a smaller, 25mm, valve was subsequently implanted.Please note, per the instructions for use artmt100122073 rev.A, "if the native annulus measurement falls between two sjm¿ masters series mechanical heart valve sizes, use the smaller size sjm¿ masters series mechanical heart valve." "the two retention sutures on the valve holder/rotator must be cut and removed before the sjm¿ masters series mechanical heart valve can be rotated." "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 VALVE EXPANDED CUFF
• 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: 7923490
• Report Number: 2648612-2018-00085
• Device Sequence Number: 1437792
• Product Code: LWQ
• UDI-Device Identifier: 05414734006453
• UDI-Public: 05414734006453
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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: 03/06/2023
• Device Model Number: 27MECJ-502
• Device Catalogue Number: 27MECJ-502
• Device Lot Number: 6351961
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 01/07/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 66