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 Pneumonia (2011); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/09/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

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

Event 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.

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
• 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: 17204648
• MDR Text Key: 317953351
• Report Number: 2135147-2023-02786
• 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: 08/09/2023

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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG