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

Model Number	31MECJ-502
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Occlusion (1984); Low Cardiac Output (2501)
Type of Reportable Event	Serious Injury
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 31mm masters series valve expanded cuff was selected for implant in the patient.Prior to the procedure the leaflets were checked multiple times using a q-tip, but once the device was implanted one leaflet would not open.The device was removed from the patient and the leaflets appeared to open and close normally outside the annulus.A 33mm medtronic hancock tissue mitral valve was implanted instead and the procedure was completed.The patient did experience a low output syndrome from the 3 aortic cross clamps during the procedure.
Additional Manufacturer Narrative
The reported event of one leaflet not opening could not be confirmed.No anomalies were found with the valve, and functional testing upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.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 reported event could not be conclusively determined.

• 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: 10992634
• Report Number: 2648612-2020-00137
• Device Sequence Number: 3699158
• Product Code: LWQ
• UDI-Device Identifier: 05414734006613
• UDI-Public: 05414734006613
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 02/26/2025
• Device Model Number: 31MECJ-502
• Device Catalogue Number: 31MECJ-502
• Device Lot Number: 7415391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 02/10/2021
• 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