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

Model Number	29MECJ-502
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of a dislodged and fractured leaflet was confirmed.One leaflet was fractured and both were 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.The cause of the leaflet dislodgment could not be conclusively determined.Please note, per the instructions for use artmt100045600 version 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 and "never apply force to the valve leaflets.Force may cause structural damage to the valve.".
Event or Problem Description
On (b)(6) 2020, a 29mm sjm masters series valve expanded cuff (serial#: (b)(4)) was selected for implant in the patient.During the mitral valve replacement, the valve was implanted and sutured.When the physician attempted to rotate the valve using the holder, a click was heard and one of the leaflets popped out.The physician tried to force the leaflet in and the leaflet broke into pieces.All of the pieces were fished out of the patient and the valve was explanted.After the valve was explanted, a new valve was sourced from a nearby hospital and a new 29mm sjm masters series valve expanded cuff( serial#1: (b)(4)) was successfully implanted and the procedure was completed.The patient was on cardiac bypass for an extended time, as the procedure was extended by an hour.The patient remained hemodynamically stable throughout the procedure, there were no serious injuries and the patient was discharged from the icu 3 days later.

• 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 ; RQ 00725
• MDR Report Key: 10718552
• Report Number: 2648612-2020-00105
• Device Sequence Number: 16441970
• Product Code: LWQ
• UDI-Device Identifier: 05414734006545
• UDI-Public: 05414734006545
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

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: 03/10/2025
• Device Model Number: 29MECJ-502
• Device Catalogue Number: 29MECJ-502
• Device Lot Number: 7435814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/22/2020
• 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