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

Model Number	19MHPJ-505
Medical Device Problem Codes	Fracture (1260); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2014, a 19mm masters mitral valve was selected for implant.On (b)(6) 2025, it was noted that there was a general narrowing of the valve as the patient grew, so it was decided to replace the valve.During the removal of the mechanical valve, one of the leaflets became damaged and fragments fell into the left ventricle.Most of the fragments were retrieved, but a few sand-sized pieces could not be found.The left ventricle was washed with 2 liters of saline.After that, the left ventricle was checked again to confirm that there were no fragments.An x-ray was taken, but no fragments were found.The device was replaced with an 25mm masters valve.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
An event of valve leaflet fracture and patient-device incompatibility was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported event of valve fracture could not be conclusively determined but may have been caused by some external force being applied to explant the valve which overstressed the carbon material.The cause of patient-device incompatibility was due to patient growth.The reported surgical intervention was under case-specific circumstances as device was surgically removed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on 15 dec.2014, a 19mm masters mitral valve was selected for implant.On (b)(6) 2025, it was noted that there was a general narrowing of the valve as the patient grew, so it was decided to replace the valve.During the removal of the mechanical valve, one of the leaflets became damaged and fragments fell into the left ventricle.Most of the fragments were retrieved, but a few sand-sized pieces could not be found.The left ventricle was washed with 2 liters of saline.After that, the left ventricle was checked again to confirm that there were no fragments.An x-ray was taken, but no fragments were found.The device was replaced with an 25mm masters valve.

• Brand Name: MASTERS SERIES EXPANDED HEMODYNAMIC PLUS 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: 22171176
• Report Number: 2135147-2025-03061
• Device Sequence Number: 18443780
• Product Code: LWQ
• UDI-Device Identifier: 05415067043719
• UDI-Public: (01)05415067043719(17)190120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 06/24/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2019
• Device Model Number: 19MHPJ-505
• Device Catalogue Number: 19MHPJ-505
• Device Lot Number: 4430707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2014
• 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: Required Intervention
• Patient Age: 12 YR
• Patient Sex: Unknown
• Patient Weight: 38 KG