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

Model Number	27CAVGJ-514 00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2023
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.Na.
Event or Problem Description
It was reported that on (b)(6) 2023, a 27mm sjm masters series coated aortic valved graft was chosen for implant.After the device was placed and secured, it was noticed that of the leaflets was not in its housing.No instruments were in contact with the valve at the time of dislodgement.The leaflet was retrieved from the left ventricle and the device was explanted.An unknown size non-abbott valve was successfully implanted as a replacement device.The patient remained hemodynamically stable throughout the procedure and no clinically significant delay was reported.The patient was reported as stable.
Additional Manufacturer Narrative
An event of a leaflet being dislodged was reported.The investigation confirmed that one leaflet was dislodged from the orifice and returned unfractured in entirety.Information from the field indicated that no other instruments encountered the valve at the time of fracture.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There was no evidence of the material defect in the carbon coating that may have caused or contributed to the dislodged leaflet.Based on the information received, the root cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of 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): 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: 16900343
• Report Number: 2135147-2023-02006
• Device Sequence Number: 5561796
• Product Code: LWQ
• UDI-Device Identifier: 05414734006422
• UDI-Public: 05414734006422
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 07/05/2023

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 Model Number: 27CAVGJ-514 00
• Device Catalogue Number: 27CAVGJ-514 00
• Device Lot Number: 8818206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2022
• 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 Age: 41 YR
• Patient Sex: Male