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 Ventricular Fibrillation (2130); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/01/1990

Event Type  Death  

Manufacturer Narrative

Summarized patient outcomes/complications of outcomes after mechanical aortic valve replacement in children with congenital heart disease were reported in a research article in a subject population with multiple co-morbidities including aortic stenosis, aortic regurgitation, bicuspid/quadricuspid aortic valves, congenital aortic valve disease, conotruncal anomaly, connective tissue disorder, marfan syndrome, loeys-dietz syndrome, turner syndrome, noonan syndrome/charge syndrome, prior catheter-based or surgical intervention, prior procedure for aortic valve.Some of the complications reported were death, heart failure, ventricular tachycardia, surgical intervention, hospitalization, pannus these complications are anticipated for the procedure and subject population.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.The additional patient effects and malfunctions reported in the article are captured under separate reports.Literature attachment: article title: outcomes after mechanical aortic valve replacement in children with congenital heart diseasena.

Event Description

The article, ¿outcomes after mechanical aortic valve replacement in children with congenital heart disease¿, was reviewed.The article presented a retrospective single center study that investigated the outcomes following avr using mechanical prostheses in children.Devices included in this study were st.Jude (abbott, santa clara, ca, usa), on-x (cryolife, kennesaw, ga, usa), ats (medtronic, minneapolis, mn, usa), and mira (edward lifesciences, irvine, ca, usa).The article concluded mechanical avr could be performed safely in children.Younger age, longer cardiopulmonary bypass time and smaller valve size were associated with adverse events.Thromboembolic or hemorrhagic complications might rarely occur.[the primary and corresponding author was chun soo park, division of pediatric cardiac surgery, asan medical center, university of ulsan college of medicine, seoul, with corresponding email: chunsoo@amc.Seoul.Kr].

• 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: 17904716
• MDR Text Key: 325287051
• Report Number: 2135147-2023-04406
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• 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: 09/15/2023
• 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): Death