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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problems Incomplete Coaptation (2507); Patient-Device Incompatibility (2682)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Movement Disorder (4412)

Event Date 10/01/2023

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title " a case of left ventricular pressure estimation by transthoracic echocardiography was useful for artificial aortic valve dysfunction after bentall operation.

Event Description

The article, "a case of left ventricular pressure estimation by transthoracic echocardiography was useful for artificial aortic valve dysfunction after bentall operation", was reviewed.The article presented a case study of a 50-year-old male patient with prior ascending aorta replacement procedure 11 years ago due to acute type a aortic dissection.It was reported that on an unknown date, an unknown 23mm abbott/sjm mechanical heart valve was implanted for a bentall procedure with 26mm open stent graft and concomitant coronary artery bypass graft for pseudoaneurysm at proximal site.It was then reported on an unknown date post-procedure, the patient presented with shortness of breath on exertion, wobble, and dropped blood pressure.Systolic murmur was detected on auscultation.Chest x-ray and chest ct showed limited mobility of one leaflet for the valve implanted in aortic position.One leaflet was confirmed 82 degrees as maximum open angle and another the other valve's angle was 63 degrees which did not reach the normal angle as 85 degrees.Low-density area was detected at sub-valvular area which was suspected to be pannus.The patient was treated with warfarin to rule out thrombus but no improvement was observed by transthoracic echocardiography one month later.Pannus ingrowth was confirmed along the felt of the prosthetic vessel basal suturing area.Effective valvar orifice area become narrowed by nearly half from the original size due to pannus.A decision was made to explant the valve and remove the attached pannus to the annulus.A 19mm regent mechanical valve was implanted and the patient symptoms improved after procedure.[the primary and corresponding author was yoshimasa baba, national hospital organization kagoshima medical center, japan].

Manufacturer Narrative

As reported in a research article, a case of left ventricular pressure estimation by transthoracic echocardiography was useful for artificial aortic valve dysfunction after bentall operation.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.Literature attachment: article title "a case of left ventricular pressure estimation by transthoracic echocardiography was useful for artificial aortic valve dysfunction after bentall operation".

• 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: 18978154
• MDR Text Key: 338592637
• Report Number: 2135147-2024-01339
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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
• Date Manufacturer Received: 04/05/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 60 KG