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

Catalog Number	19AGFN-756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	07/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of sudden breathing changes, cardiac arrest, ventricular fibrillation, and unresponsive exhalation 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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Clinical information: crd_1036 - regent china pmcf, patient site id: (b)(6).It was reported that on 13 july 2023, an 19mm sjm regent heart valve w/ flex cuff was implanted.On (b)(6) 2023, the patient drank 600-700ml of water at once and suddenly experienced respiratory changes, cardiac arrest, and unresponsive exhalation.Both pupils were dilated and slow to react to light.Cardiac compressions were performed immediately.Electrocardiogram (ecg) showed ventricular fibrillation.Endotracheal intubation was given immediately.Electrical defibrillation was conducted, medication was administered, and ventricular fibrillation was resolved.Sedation and analgesia were given to the patient.Ejection fraction was 36%.The patient had a history of poor ventricular function and chronic heart failure, which was believed to have caused this event.An echocardiogram on (b)(6) 2023 showed that the valve was working well.The patient was reported to be using ventilator assisted breathing and was placed on tracheal intubation.

• 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: 17463692
• Report Number: 2135147-2023-03433
• Device Sequence Number: 2698477
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• 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
• Report Date (Section B): 08/04/2023

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 Catalogue Number: 19AGFN-756
• Device Lot Number: C00008688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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; Life Threatening; Hospitalization
• Patient Sex: Unknown