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

Catalog Number	27MECJ-502
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Dyspnea (1816); Endocarditis (1834); Insufficient Information (4580)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in 2008, a 27mm masters valve was selected for implant.On an unknown date, the patient presented with shortness of breath.The valve was noted to have paravalvular leak and the patient was diagnosed with endocarditis.On 15 aug.2024, a 14x5mm amplatzer vascular plug iii was selected for implant to treat the mitral paravalvular leak.The leak was difficult to access due to the septal position.The exact size of the leak was difficult to assess but based on the jet width and length, the leak was considered as severe.The amplatzer device was then deployed and released.Following the device release, the tee exam showed an unexpected moderate leak next to the device at 12:00pm (aortic side).The physician tried to cross the remaining leak in preparation for a second device but given the complexity decided to stop the procedure and will follow the patient.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.
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 in 2008, a 27mm masters valve was selected for implant.On an unknown date, the patient presented with shortness of breath.The valve was noted to have paravalvular leak and the patient was diagnosed with endocarditis.On (b)(6) 2024, a 14x5mm amplatzer vascular plug iii was selected for implant to treat the mitral paravalvular leak.The leak was difficult to access due to the septal position.The exact size of the leak was difficult to assess but based on the jet width and length, the leak was considered as severe.The amplatzer device was then deployed and released.Following the device release, the tee exam showed an unexpected moderate leak next to the device at 12:00pm (aortic side).The physician tried to cross the remaining leak in preparation for a second device but given the complexity decided to stop the procedure and will follow the patient.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.
Additional Manufacturer Narrative
An event of shortness of breath, perivalvular leak and endocarditis were reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information from the field indicated that the exact size of the leak was difficult to assess but based on the jet width and length, the leak was considered as severe.Reportedly, tee exam showed an unexpected moderate leak next to the device after deployed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received the cause of the reported incident could not conclusively be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES VALVE EXPANDED CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20180560
• Report Number: 2135147-2024-04411
• Device Sequence Number: 8261895
• Product Code: LWQ
• UDI-Device Identifier: 05415067045232
• UDI-Public: (01)05415067045232(17)130421(10)0002652976
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 10/30/2024

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: 04/21/2013
• Device Catalogue Number: 27MECJ-502
• Device Lot Number: 0002652976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2008
• 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: 59 YR
• Patient Sex: Female