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	Ischemia (1942)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 27mm masters valve was selected for implant.After implant, the surgeon observed that a disc of the prosthesis became dislodged after rotation.The leaflet was retrieved and the valve was explanted.A second 27mm masters valve was implanted.Per the user, the patient remained hemodynamically stable throughout the procedure, but post-operatively, the patient remained in the icu longer and more ischemia time (bypass time) was reflected due to the need for additionally vasopressors and inotropic drugs.The patient is reported to be stable and discharged.
Additional Manufacturer Narrative
The reported event of a ¿disc of the prosthesis became dislodged after rotation¿ could not be confirmed.Both leaflets of the returned masters series mechanical heart valve were returned seated within the orifice and able to fully open and close with no resistance occurring.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the leaflet dislodgement remains unknown.

• 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: 8342075
• Report Number: 2648612-2019-00009
• Device Sequence Number: 1954713
• Product Code: LWQ
• UDI-Device Identifier: 05414734006453
• UDI-Public: 05414734006453
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/11/2019

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: 06/13/2023
• Device Model Number: 27MECJ-502
• Device Catalogue Number: 27MECJ-502
• Device Lot Number: 6502217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/11/2019
• 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