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

Model Number	15MHPJ-505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/10/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
An event of patient death was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicated, "the patient died due to the clinical conditions of the patient and not as a result of the performance of the device.".
Event or Problem Description
On (b)(6) 2018, a 15mm mechanical heart valve was implanted in a (b)(6) born with complex congenital heart disease consisting of a double outlet right ventricle and coronary anomaly.Prior surgical interventions included ventricular defect closure, arterial switch procedure and mitral valvuloplasty.The patient remained hospitalized in the intensive care unit.Following the valvuloplasty, the patient underwent a mitral valve replacement due to the presence of severe mitral insufficiency as an attempt to save the (b)(6) life.Post-procedure, the patient remained persistently unstable and in the icu on inotropes.On (b)(6) 2018, the patient died due to the clinical conditions of the patient and not as a result of the performance of the device.

• 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
• MDR Report Key: 7779482
• Report Number: 3007113487-2018-00015
• Device Sequence Number: 1084976
• Product Code: LWQ
• UDI-Device Identifier: 05415067016522
• UDI-Public: 05415067016522
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2018

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: 12/14/2020
• Device Model Number: 15MHPJ-505
• Device Catalogue Number: 15MHPJ-505
• Device Lot Number: 5328899
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/13/2018
• 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: Death
• Patient Age: 3 MO