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

Model Number 15AHPJ-505

Device Problem Obstruction of Flow (2423)

Patient Problems Death (1802); Thrombus (2101)

Event Date 02/14/2017

Event Type  Death  

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 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.

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
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 9496800
• MDR Text Key: 172045216
• Report Number: 3007113487-2019-00041
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05415067016515
• UDI-Public: 05415067016515
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 3