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

Model Number	25MJ-501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Ventricular Fibrillation (2130)
Date of Event	03/12/2018
Type of Reportable Event	Serious Injury
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) 2018, a 25mm masters valve was implanted due to regurgitation and coronary heart disease.During a follow-up visit on (b)(6) 2018, the patient was noted to have pre-operative ventricular fibrillation and post-operative cardiogenic shock.The patient was reported to have expired.
Additional Manufacturer Narrative
An event of pre-operative ventricular fibrillation, post-operative cardiogenic shock, and patient death due to post-operative complications 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 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.
Event or Problem Description
On (b)(6) 2018, a 25mm masters valve was implanted due to regurgitation and coronary heart disease.During a follow-up visit on (b)(6) 2018, the patient was noted to have pre-operative ventricular fibrillation and post-operative cardiogenic shock.The patient was reported to have expired the same day due to post-operative complications.Per the site, the death is unrelated to the device performance.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART 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: 9329484
• Report Number: 2648612-2019-00097
• Device Sequence Number: 16248070
• Product Code: LWQ
• UDI-Device Identifier: 05414734006354
• UDI-Public: 05414734006354
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 08/29/2021
• Device Model Number: 25MJ-501
• Device Catalogue Number: 25MJ-501
• Device Lot Number: 5625029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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
• Patient Age: 66 YR