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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problem Off-Label Use (1494)

Patient Problems Endocarditis (1834); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/05/2024

Event Type  Injury  

Event Description

The article "modified commando procedure using a double valve composite through an aorto-annulo-septotomy" was reviewed.The article presented a case study showing successful a commando procedure in a patient with prosthetic valve endocarditis (pve) utilizing a double valve composite through an aorto-annulo-septostomy.On an unknown date estimated as (b)(6) 2020, the patient received a double valve replacement with a 20mm non-abbott valve and a 25mm abbott mechanical heart valve for infectious endocarditis.The patient recently developed prosthetic valve endocarditis and worsening heart failure, so a redo double valve replacement was performed on an estimated date of (b)(6) 2024.The article concluded that they successfully performed a modified commando procedure for pve.An aorto-annulo-septotomy provided a good field of vision at the combined aortic and mitral annuli without incising the left atrial roof.The double valve composite with four layer patch wings was useful for performing dvr en bloc and aorto-annulo-septostomy closure serially.[the primary author and corresponding author was kanji matsuzaki md, hitachi general hospital, ibaraki, japan with corresponding email : (b)(4)].Peri and post procedural complications include endocarditis, heart failure, surgical intervention, hospitalization, medical intervention (medication), permanent pacemaker, heart block.

Manufacturer Narrative

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

Manufacturer Narrative

As reported in a research article, modified commando procedure using a double valve composite through an aorto-annulo-septotomy.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.Please note, per regent mechanical heart valve, instructions for use, (b)(6), revision a.6, " indications: the sjm regent¿ mechanical heart valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve.This device may also be used to replace a previously implanted aortic prosthetic heart valve." this is considered as an off-label use of the device.However, it was unable to determine if the off-label use contributed to the reported incident.Therefore, a letter will not be provided to address the deviation from the ifu.

• Brand Name: UNKNOWN MECHANICAL 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: 18915006
• MDR Text Key: 337793901
• Report Number: 2135147-2024-01138
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

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 Catalogue Number: UNK MECHANICAL HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 52 YR
• Patient Sex: Male