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

Catalog Number UNK MECHANICAL HEART VALVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Edema (2020); Valvular Stenosis (2697)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An article from the examination and technology (jpn), 50(9): 2022, 972-973.Issn; 0301-2611; report a case of a 29mm unknown sjm mechanical heart valve which was implanted in a mitral position on unknown date and year.On unknown date and year, an echocardiography performed, and the following findings were detected.Ivs 10 mm, pwt 9 mm, lvdd 42 mm, lvds 23 mm, fs 45%, ef 76% lad 51 mm, aod 33 mm, aortic root 27 mm.Lv mass 145 g, index 88 g/m2, rvsp 45 mmhg, one leaflet had become immobilized.The other leaflet which had been in motion, had also opened incompletely.Therefore, the annulus was severely stenosed.The material adhering onto the leaflets was not able to be identified though, thrombus was suspected.Although the left ventricular function was within normal, right ventricle pressure was being increased and right pulmonary effusion was confirmed.There is no further information available whether any treatment was performed to this patient.[the primary author and corresponding author of this article is tadashi, tanemura, md, 3-chome-2-19 nishiazabu minato city, tokyo 106-0031 japan].

Event Description

N/a.

Manufacturer Narrative

An event of right pulmonary effusion and one of the leaflets being immobilized was reported.A more comprehensive assessment, including histopathological examination of the valve could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.D4: the udi number is not known as the lot and serial number were not provided.

• 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: 15652530
• MDR Text Key: 302249985
• Report Number: 2135147-2022-01729
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• 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: 12/22/2022
• 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): Other