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

Catalog Number UNK MECHANICAL HEART VALVE

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

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 09/12/2023

Event Type  Death  

Manufacturer Narrative

As reported in a research article, outcomes after mechanical aortic valve replacement in children with congenital heart disease.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: outcomes after mechanical aortic valve replacement in children with congenital heart disease.

Event Description

The article, ¿outcomes after mechanical aortic valve replacement in children with congenital heart disease¿, was reviewed.The article presented a case study of a 66-month-old female patient with hypertrophic obstructive cardiomyopathy.It was reported on an unknown date, a 19mm unknown st.Jude medical mechanical valve was implanted.The patient's annulus size was 16.8mm.It was reported the patient passed away 1 day post-procedure while on extracorporeal membrane oxygenation (ecmo) and the cause of death was low cardiac output syndrome.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: 17905071
• MDR Text Key: 325291451
• Report Number: 2135147-2023-04416
• 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

• 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: 09/15/2023
• Initial Date FDA Received: 10/10/2023
• 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
• Patient Age: 66 MO
• Patient Sex: Female
• Patient Weight: 11 KG