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 Hematoma (1884); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

An event of thrombus on a mechanical valve leaflet which was restricting the leaflets motion was reported through a research article.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional patient information was received for analysis.Based on the available information, the root cause of the reported event of could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

An article from the japanese society of intensive care medicine was reviewed.The research article presents a case of a one year and 10 month old female infant.Norwood procedure was performed for double-outlet right ventricle (dorv).A 17mm sjm mechanical heart valve was implanted in an aortic position due to aortic regurgitation after norwood procedure.A leaflet click sound became inaudible two month after aortic valve replacement (avr).It was diagnosed that thrombi adhered onto the leaflet which interfered leaflet motion.The patient was administered t-pa 0.045mg/kg/hr.And heparin 9.3u/kg/hr.T-pa was increased up to 0.063mg/kg/hr.As maximum administration.6days administration improved the leaflet motion.Mild subcutaneous hematoma was observed as side-effect.Hemodynamic status was stable throughout this event.No additional information was available.[ the author and corresponding author of this article is hayashi, ken, md, kobe city medical center general hospital japan, 650-0047 hyogo, kobe, chuo ward, minatojima minamimachi, 2 chome-1-1 tel: +011(081)783024321 ].

• 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: 14804571
• MDR Text Key: 295067896
• Report Number: 2135147-2022-00427
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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: 05/31/2022
• 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): Required Intervention
• Patient Age: 22 MO
• Patient Sex: Female