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

Model Number	15AHPJ-505
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2019
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
It was reported a patient underwent implant of a 15 mm sjm masters series hemodynamic plus valve on (b)(6) 2019.During the procedure the patient began to hemorrhage resulting in the patient requiring packed red blood cell replacement, factor 7 and a tranexamic acid infusion.The patient remained tachycardic and was monitored in the cardiac intensive care unit.On (b)(6) 2019, the patient developed hypoxia during their chest closure procedure.The patient was extubated on (b)(6) 2019 and developed a pneumothorax post chest tube removal on (b)(6) 2019.No additional information has been provided.Us5146-10, crd_945-surgical aortic valve pas, (b)(4).
Additional Manufacturer Narrative
This event was reported in error as there are no allegations of malfunction and/or adverse event related to the 15mm sjm masters series hemodynamic plus valve.Prior to procedure, the patient had a "fontan" circulation.At baseline, patient was cyanotic (oxygen saturation at rest were in the 70-80% range).The patient's family had rejected transplantation as an option, therefore the patient underwent a complex and difficult operation requiring both a fontan surgery as well as an aortic valve replacement using a 15mm sjm masters series hemodynamic plus valve.Information received indicated that the during the procedure the patient began hemorrhaging from the suture lines along the aorta and pulmonary arteries, both of which required reconstruction as part of the complicated fontan surgery.The operation was very complex and required a long period of cardiopulmonary bypass.The duration of the bypass was related to the difficulty and complexity of the required reconstruction related to the fontan surgery.The hemorrhage and the prolonged cardiopulmonary bypass time was reported not to be related to the valve or the implant procedure for the valve but directly related to the fontan reconstruction surgery.There were no allegations against the implant of the masters valve or the valve itself.The valve was successfully implanted and working as intended.The patient recovered and was discharged from the hospital in good condition.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13286688
• Report Number: 3007113487-2022-00023
• Device Sequence Number: 14634721
• Product Code: LWQ
• UDI-Device Identifier: 05415067016515
• UDI-Public: 05415067016515
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2023
• Device Model Number: 15AHPJ-505
• Device Catalogue Number: 15AHPJ-505
• Device Lot Number: 6323166
• Was Device Available for Evaluation?: No
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 27 KG
• Patient Ethnicity: Hispanic
• Patient Race: White