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

Model Number	21AHPJ-505
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Heart Failure (2206)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received in abbott patient device tracking that on (b)(6) 2018, a 21mm masters valve was implanted.The patient had an aortic and mitral valve replacement, as well as a coronary artery bypass graft procedure.The surgery was completed without sequelae.It is reported that the patient went into cardiogenic failure after the procedure due to an unknown cause.The patient family did not want to escalate care and the patient died.Abbott has been informed no additional details will be provided.
Additional Manufacturer Narrative
An event of patient death 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.Based on the information received, the cause of the reported incident could not be conclusively determined; however, it was reported that the patient went into cardiogenic failure after the procedure due to an unknown cause.The patient's family did not want to escalate care and the patient died. .

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8380760
• Report Number: 2648612-2019-00015
• Device Sequence Number: 16557000
• Product Code: LWQ
• UDI-Device Identifier: 05414734006002
• UDI-Public: 05414734006002
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2023
• Device Model Number: 21AHPJ-505
• Device Catalogue Number: 21AHPJ-505
• Device Lot Number: 6468488
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/29/2019
• 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; Other