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

Catalog Number	29MJ-501
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Unspecified Infection (1930); Respiratory Tract Infection (2420); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Embolism/Embolus (4438); Heart Failure/Congestive Heart Failure (4446)
Date of Event	04/17/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2021, a 29mm masters mitral mechanical heart valve was implanted.On (b)(6) 2024, sudden heart failure occurred and the patient was hospitalized.Ultrasound imaging showed a dislodged valve leaflet.The valve was surgically removed and replaced, however the dislodged leaflet was not recovered and its embolized to common iliac artery.The patient was reported to be unstable.The patient remained in the intensive care unit (icu) on a ventilator until the patient passed away on (b)(6) 2024.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of sudden heart failure occurred, patient hospitalization, leaflet dislodgement and death was reported.Information from the field indicated that the dislodged leaflet was not recovered and its embolized to common iliac artery.The device was returned to abbott for analysis and the investigation revealed that the valve was returned with one leaflet intact and mobile.There was no indication of fracture or damage to the intact leaflet.There was minor chipping on the orifice ring and what appeared to be a crack.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported leaflet dislodgement and patient death could not conclusively be determined.
Event or Problem Description
Subsequent to the previously filed report, additional information was received.It was reported that on (b)(6) 2021, a 29mm masters mitral mechanical heart valve was implanted.On (b)(6) 2024, sudden heart failure occurred and the patient was hospitalized.Ultrasound imaging showed a dislodged valve leaflet.The valve was surgically removed and replaced, however the dislodged leaflet was not recovered and its embolized to common iliac artery.There was a partial blockage of blood flow.The patient was reported to be unstable.The patient remained in the intensive care unit (icu) on a ventilator.In the opinion of the physician, the embolized leaflet led to acute heart failure and eventually infections of organs throughout the body until the patient passed away on (b)(6) 2024 from a severe lung infection.
Additional Manufacturer Narrative
A sudden heart failure event occurred in a patient, which resulted in hospitalization, leaflet dislodgement, and subsequent death.It was indicated that the dislodged leaflet was not recovered and had embolized to the common iliac artery.The device was returned to abbott for analysis, and the investigation revealed that the valve was returned with one intact and mobile leaflet, with no indications of fracture or damage to the intact leaflet.Upon examination, the device was sent to pathology, which identified patchy white fibrous pannus on the inflow surface that did not extend onto the mechanical components.Microscopic analysis of the sewing cuff revealed fibrous tissue consistent with pannus formation, but no signs of inflammation were present.Further analysis of the device's orifice revealed minor chipping on the outer diameter of the orifice rim (outflow side).Upon closer examination under a microscope and scanning electron microscopy (sem), a hairline fracture originating from the chips was identified, extending into the orifice sewing seat.This fracture appeared to be surface-level and located within the carbon coating, which could have contributed to the leaflet dislodgement over time.However, it cannot be determined when the damage to the orifice occurred.A review of the device history record confirmed that all manufacturing and inspection operations were completed, and the product met all specifications.

• Brand Name: MASTERS SERIES MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19297279
• Report Number: 2135147-2024-02134
• Device Sequence Number: 12507596
• Product Code: LWQ
• UDI-Device Identifier: 05415067045058
• UDI-Public: (01)05415067045058(17)250716(10)7590820
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2025
• Device Catalogue Number: 29MJ-501
• Device Lot Number: 7590820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 10/23/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 09/20/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 72 KG