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

Model Number	15AHPJ-505
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
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 (b)(6) 2021, a 15mm aortic masters series hemodynamic plus valve was implanted.On (b)(6) 2022, there are increased gradient noted on the valve and a surgical intervention was planned, however has not yet been performed.The patient status was reported as unknown.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: the valve was not explanted only cleaned (removal of peel -tissue).Afterwards the valve functioned.The patient is stable.
Additional Manufacturer Narrative
An event of high gradient about a year and a half after the valve was implanted was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the valve was not removed but that the "peel -tissue" was cleaned off the valve, at which point the valve functioned again.The cause of the gradient noted could be due to the presence of the "peel -tissue".There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6: medical device codes 4580, 4648, 4641 and 4066 were removed.

• Brand Name: MASTERS SERIES 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#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: 15960255
• Report Number: 2135147-2022-02494
• Device Sequence Number: 5550156
• Product Code: LWQ
• UDI-Device Identifier: 05415067016515
• UDI-Public: 05415067016515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 03/20/2023

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: 06/08/2024
• Device Model Number: 15AHPJ-505
• Device Catalogue Number: 15AHPJ-505
• Device Lot Number: 7037598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• 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 Sex: Unknown