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

Model Number	19AGN-751
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Death (1802); Thrombus (2101)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of explant due to thrombosis and patient death due to right ventricle failure 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) 2019, the patient was hospitalized for analysis with symptoms of dyspnea and syncope.On (b)(6) 2019, a regent mechanical heart valve was implanted in the aortic position.While the patient was hospitalized postoperatively the patient was on anticoagulation therapy (clexane).A week later on (b)(6) 2019, the device was explanted due to thrombosis and replaced with a 19mm intuity valve.The inr level was 2.On (b)(6) 2019, the patient died due to right ventricle failure.The patient's comorbidities included: hypertension, anxious syndrome, and gastrointestinal reflux.
Event or Problem Description
On (b)(6) 2019, the patient was hospitalized for analysis with symptoms of dyspnea and syncope.On (b)(6) 2019, a regent mechanical heart valve was implanted in the aortic position.While the patient was hospitalized postoperatively the patient was on anticoagulation therapy (clexane).A week later on (b)(6) 2019, the device was explanted due to thrombosis and replaced with a 19mm intuity valve.The inr level was 2.On (b)(6) 2019, the patient died due to right ventricle failure.The patient's comorbidities included: hypertension, anxious syndrome, and gastrointestinal reflux.

• Brand Name: SJM REGENT 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: 9186206
• Report Number: 2648612-2019-00084
• Device Sequence Number: 2460304
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: 05414734005869
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 06/24/2024
• Device Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: 7064753
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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; Required Intervention