MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART COATED AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL

Catalog Number	27CAVGJ-514 00
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on an unknown date, a 27mm sjm masters series coated aortic valved graft was chosen for a procedure.The valve graft appeared normal during preparation.During procedure, the surgeon found large amount of yellow dots inside the conduit.The conduit was implanted.The patient remained hemodynamically stable throughout the procedure.There was a delay in the procedure.The patient was reported discharged.
Additional Manufacturer Narrative
An event of a large number of dots being found inside a conduit during procedure was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The holder was returned to abbott for investigation and the analysis found that there was foreign material located throughout its body.The device was sent to the science and technology lab for further testing which revealed that given the visual, mechanical, and chemical properties of the fm, the material is of proteinaceous origins and is plausibly a known surgical hemostatic matrix or surgical sealant.As a result of this finding, abbott is performing further investigation, per internal procedures.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
H6.Medical device problem code: 2017 improper or incorrect procedure or method was added.An event of a large number of dots being found inside a conduit during procedure was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The holder was returned to abbott for investigation and the analysis found that there was foreign material located throughout its body.The device was sent to the science and technology lab for further testing which revealed that given the visual, mechanical, and chemical properties of the fm, the material is of proteinaceous origins and is plausibly a known surgical hemostatic matrix or surgical sealant.As a result of this finding, abbott is performing further investigation, per internal procedures.Please note, per instructions for use, "warning: examine the packaging carefully, and ensure the tray is unopened and unbroken, and verify that the sjm¿ masters series aortic valved graft is seated in the tray.If you note any damage, do not use the device.".

• Brand Name: MASTERS SERIES HEART COATED AORTIC VALVED GRAFT
• 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: 19838254
• Report Number: 2135147-2024-03617
• Device Sequence Number: 17867468
• Product Code: LWQ
• UDI-Device Identifier: 05415067044112
• UDI-Public: (01)05415067044112(17)281224(10)10133694
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 27CAVGJ-514 00
• Device Lot Number: 10133694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 12/06/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/26/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2023
• 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
• Patient Sex: Unknown