MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number	23AGFN-756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Syncope/Fainting (4411)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: crd_1036 - regent china pmcf, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 23mm sjm regent heart valve with flex cuff was implanted during an aortic valve replacement.It was noted during procedure that the patient had pericardial symphysis.Other concomitant procedures performed were mitral valve replacement, triple cardiopulmonary bypass, and pericardial denudation.On (b)(6) 2023, patient had ventricular fibrillation and loss of consciousness, requiring cardiopulmonary resuscitation, tracheal intubation, and intravenous injection of adrenaline.Multiple rounds of defibrillation and adrenaline injections were performed to restore an autonomous heartbeat.Blood pressure remained low at 63/43mmhg.Adrenaline injections were continued, and the amount of norepinephrine was increased.The patient had been placed on an intra-aortic balloon pump (iabp) after procedure on (b)(6) 2023.Ice was applied to the head to cool down and protect the brain.The patient's blood pressure was monitored by the radial artery, which was close to that monitored by the iabp.Methylene blue was provided due to the low peripheral vascular resistance.The patient status was reported as stable.The cause of the event is attributed to the patient's blood pressure and own physician condition.There is no current allegation of malfunction against the 23mm sjm regent heart valve with flex cuff or the procedure.
Additional Manufacturer Narrative
An event of ventricular fibrillation and loss of consciousness was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.However, field noted that the cause of event was patient's blood pressure and own physician condition.There is no current allegation of malfunction against the device or the procedure.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17101067
• Report Number: 2135147-2023-02509
• Device Sequence Number: 19330007
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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 Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG