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	Pneumonia (2011); Heart Failure/Congestive Heart Failure (4446)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(6), patient site id: (b)(6) (r758215401, r758213001).It was reported that on (b)(6) 2023, a 23mm sjm regent heart valve with flex cuff was successfully implanted in a patient.There was no difficulty implanting the valve noted.The patient had remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.It was noted following the implant procedure that the patient had a low cardiac output.The decision was made to place the patient on an intra-aortic balloon pump.On (b)(6) 2023, the patient was administered and digoxin.On (b)(6) 2023, the patient administered levosimendan and landiolol.On (b)(6) 2023, it was noted that the patient began to suffer from a nosocomial pneumonia infection.The decision was made to intubate the patient for mechanical ventilation therapy.The patient was also started on imipenem and cilstatin.On (b)(6) 2023, the decision was made to perform a cardioversion due to the patient's atrial fibrillation.On (b)(6) 2023, the patient was administered tigecycline.On (b)(6) 2023, the patient was weaned off the intra-aortic balloon pump, as their systolic function was normal and their circulation had stabilized.On (b)(6) 2023, it was noted that the patient's condition had began to improve and the patient remains on anti-infective treatment.The patient's low cardiac output it attributed to the patient's past medical history and the patient's condition in the intensive care unit prior to the implant procedure.There is no allegation of malfunction against the abbott device or procedure.
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: (b)(6) - regent china pmcf, patient site id: (b)(6).It was reported that on 09 may 2023, a 23mm sjm regent heart valve with flex cuff was successfully implanted in a patient.There was no difficulty implanting the valve noted.The patient had remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.It was noted following the implant procedure that the patient had a low cardiac output.The decision was made to place the patient on an intra-aortic balloon pump.On (b)(6) 2023, the patient was administered and digoxin.On (b)(6) 2023, the patient administered levosimendan and landiolol.On (b)(6) 2023, it was noted that the patient began to suffer from a nosocomial pneumonia infection.The decision was made to intubate the patient for mechanical ventilation therapy.The patient was also started on imipenem and cilstatin.On (b)(6) 2023, the decision was made to perform a cardioversion due to the patient's atrial fibrillation.On (b)(6) 2023, the patient was administered tigecycline.On (b)(6) 2023, the patient was weaned off the intra-aortic balloon pump, as their systolic function was normal and their circulation had stabilized.On (b)(6) 2023, it was noted that the patient's condition had began to improve and the patient remains on anti-infective treatment.The patient's low cardiac output it attributed to the patient's past medical history and the patient's condition in the intensive care unit prior to the implant procedure.There is no allegation of malfunction against the abbott device or procedure.Subsequent to the previously filed report, additional information was received that the patient was transferred to the general ward.The patient anti-infective treatment was continued.On (b)(6) 2023, the patient's azithromycin regimen was discontinued.It was noted that the patient had recovered without fever or chill and was discharged on (b)(6) 2023.
Additional Manufacturer Narrative
An event of pneumonia, atrial fibrillation and heart failure was reported.A returned device assessment could not be performed as the device remains implanted and 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.There is no allegation of malfunction against the abbott device or procedure.Based on the information received, the root cause of the reported incident could not be conclusively determined.

• 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: 17204648
• Report Number: 2135147-2023-02786
• Device Sequence Number: 5768501
• 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): 08/09/2023

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
• Device Lot Number: C00005209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG