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

Model Number 15AHPJ-505

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Stenosis (4066)

Patient Problems Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)

Event Date 11/24/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 305276094
• Report Number: 2135147-2022-02494
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05415067016515
• UDI-Public: 05415067016515
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention