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

Model Number 15AHPJ-505

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event 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).

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
• Type of Device: 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
• MDR Text Key: 287349285
• Report Number: 3007113487-2022-00023
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05415067016515
• UDI-Public: 05415067016515
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 27 KG
• Patient Ethnicity: Hispanic
• Patient Race: White