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

Catalog Number UNK REGENT HEART VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tachycardia (2095); Heart Block (4444)

Event Date 03/23/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article abstract, "an infant who underwent ross technique/mitral valve replacement with manouguian technique for aortic/mitral valve stenosis", was reviewed.The article presents a case study of a 7-month-old, 4.9kg, male patient with prior aortic archplasty procedure presented with aortic valve stenosis, mitral valve stenosis, and pulmonary hypertension.On an unknown date, a 17mm sjm regent mechanical heart valve was chosen for procedure as part of a double valve replacement procedure.A decision was made to perform ross technique for the aortic valve and manouguian technique for the mitral valve.A 17mm sjm regent mechanical heart valve was sutured to an 18mm e-ptfe graft and then implanted in the patient's mitral annulus.It was reported the coronary arteries were then attached to the pulmonary autograft that was implanted in the aortic position.After the ascending aorta was reconstructed and cardiac pulsation resumed, complete atrioventricular (av) block was observed.A decision was made to implant a temporary pacing catheter and weaned the patient from the artificial heart-lung machine.It was then reported post-procedure, complete av block developed into a high degree av block and supraventricular tachycardia was observed.A decision was made to implant a permanent pacemaker in the patient.The patient status was reported as stable.[the primary author was jin igarashi, kanagawa children's medical center, 2 chome-138-4 mutsukawa, minami ward, yokohama, kanagawa 232-0066, japan].

Manufacturer Narrative

As reported in a research article, a patient with prior aortic archplasty procedure presented with aortic valve stenosis, mitral valve stenosis, and pulmonary hypertension.A 17mm sjm regent mechanical heart valve was chosen for procedure as part of a double valve replacement procedure.A decision was made to perform ross technique for the aortic valve and manouguian technique for the mitral valve.Then reported post-procedure, complete av block developed into a high degree av block and supraventricular tachycardia was observed.A decision was made to implant a permanent pacemaker in the patient.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device 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
• 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: 17402277
• MDR Text Key: 319830045
• Report Number: 2135147-2023-03212
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK REGENT HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 7 MO
• Patient Sex: Male