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

Model Number	15AHPJ-505
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Death (1802); Thrombus (2101)
Date of Event	02/14/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2017, a 15mm masters valve was implanted.Post implant procedure, post operative bleeding was reported and the patient received a blood transfusion.A valve thrombus was also reported and the patient was prescribed medication.On (b)(6) 2017, the patient expired due to non device related complications.
Additional Manufacturer Narrative
An event of post operative bleeding, thrombus, and patient death due to non-device related complications was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 9496800
• Report Number: 3007113487-2019-00041
• Device Sequence Number: 19352866
• Product Code: LWQ
• UDI-Device Identifier: 05415067016515
• UDI-Public: 05415067016515
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2021
• Device Model Number: 15AHPJ-505
• Device Catalogue Number: 15AHPJ-505
• Device Lot Number: 5340959
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 3