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

Model Number	23AGN-751
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Endocarditis (1834)
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
It was reported that on an unknown date, a 23mm regent valve was successfully implanted in a patient.On an unknown day in (b)(6) 2021, the patient returned with symptoms of respiratory discomfort and a fever.It was confirmed via echocardiogram that the patient had signs of bacterial induced prosthetic valve endocarditis (pve) and paravalvular leakage (pvl).The patient underwent emergency surgery.Preoperative blood cultures confirmed presence of staphylococcus capitis.The decision was made to explant the 23mm regent valve.It was noted during the explant procedure that two-thirds of the 23mm regent valve had become detached from the annulus.A composite graft was made from a 24mm valsalva graft and a 21mm non-abbott device was implanted.The patient's left and right coronary artery were both reconstructed.No bleeding was confirmed post-surgery.The patient was extubated on the 4th postoperative day and received antibiotics intravenously.No recurrence of infection was observed during postoperative follow up.The patient was discharged from the hospital on 50th postoperative day.
Additional Manufacturer Narrative
As reported in a research article, a patient had signs of bacterial induced endocarditis and paravalvular leak three months after the implant of the valve.It was noted during the explant procedure that two-third of the valve had detached from the annulus.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: REGENT HEART VALVE
• 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: 14992328
• Report Number: 2135147-2022-00492
• Device Sequence Number: 1597116
• Product Code: LWQ
• UDI-Device Identifier: 05414734006101
• UDI-Public: 05414734006101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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: 23AGN-751
• Device Catalogue Number: 23AGN-751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male