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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arrhythmia (1721); Endocarditis (1834); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title "modified commando procedure using a double valve composite through an aorto-annulo-septotomy".

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 of a 52-year-old male patient with infectious endocarditis.It was reported that on an unknown date, a 25mm unknown abbott mechanical heart valve was chosen for double valve replacement procedure along with a 20mm medtronic ats mechanical valve.It was then reported four years post-procedure, the patient presented with prosthetic valve endocarditis for both mechanical valves.The patient was treated with antibiotics for 6 weeks.Due to deteriorating heart failure, a decision was made to perform reintervention via aorto-annulo-septotomy.To replace both valves.The valves were explanted and it was noted a 5mm perforation was found at the intervalvular fibrous body (ifb).A double valve composite was made with 19mm regent and 25mm unknown abbott mechanical prostheses and patches.The replacement valves were implanted successfully.It was reported post-operatively, the patient experienced unstable conduction system and received a permanent pacemaker.Follow up transthoracic echocardiography did not confirm any abnormal function or paravalvular leak of the double valve composite.The patient was discharged 7 weeks after surgery.The article concluded this approach provided a good field of vision at the combined aortic and mitral annulus without incising the left atrial roof.The double valve composite with four-layer patch wings was useful for performing double valve replacement en-bloc and aorto-annulo-septotomy closure serially.Using these techniques, the team successfully performed the commando procedure for complicated prosthetic valve endocarditis.[the primary and corresponding author was kanji matsuzaki, hitachi general hospital, 2-1-1 jonan, hitachi, ibaraki 317-0077, japan, with corresponding email: kanji.Matsuzaki.Dh@hitachi.Com].

Manufacturer Narrative

Summarized patient outcomes/complications of mechanical heart valve were reported in a research article in a subject population with unknown co-morbidities.Some of the complications reported were endocarditis, heart failure, surgical intervention, unexpected medical intervention, hospitalization and arrhythmia.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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: 18608916
• MDR Text Key: 334141700
• Report Number: 2135147-2024-00410
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK MECHANICAL HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• 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: 52 YR
• Patient Weight: 64 KG