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

Model Number	AGFN-756
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
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
Crd_1036 - regent china pmcf.(b)(6).It was reported that on (b)(6) 2023, a 21mm sjm regent aortic mechanical heart valve was implanted in a patient.The patient had had chest distress on (b)(6) 2023, and was diagnosed with lung infections on (b)(6) 2023.On (b)(6) 2023, the results of cardiac ultrasound and left heart function measurement showed that there was a large number of refluxes around the artificial aorta valve, considering the paravalvular leakage.The patient was treated with cardiotosis and diuresis.The patient's mental condition was improved, diet was ok, sleep quality was normal, urine and feces were normal, cough was reported by patient and it was like streaks of blood in sputum on (b)(6) 2023.The patient was treated with nebulizer therapy.
Additional Manufacturer Narrative
Additional information: b5, g3, g6, h2, h6, h10 an event of massive paravalvular leakage was reported.A returned device assessment, to see if there was any anomalies with the valve 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.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Crd_1036 - regent china pmcf.Cn5793 - 278 (r757105501) subsequent to the previously filed report, additional information was received.On (b)(6)2023, transthoracic echocardiogram showed multiple refluxes around the artificial aortic valve, consider paravalvular leakage was noted.It was reported that the device was explanted and an unknown device was implanted on (b)(6)2023.

• 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: 17179057
• Report Number: 2135147-2023-02706
• Device Sequence Number: 6659210
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• 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): 07/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: C00003416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 79 KG