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

Model Number 23AGFN-756

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Syncope/Fainting (4411)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 317031843
• Report Number: 2135147-2023-02509
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG