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

Model Number 21AECJ-502

Device Problem Central Regurgitation (4068)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/17/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a 21mm aortic expd cuff masters was successfully implanted.On (b)(6) 2023, it was reported that the patient was admitted with severe aortic regurgitation.It is unknown if an intervention was performed.Patient status is unknown, no additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

An event of severe regurgitation was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.A returned device assessment could not be performed as the device was not returned for analysis.Abbott requested more information on the reported incident but did not received any further details.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: MASTERS SERIES VALVE EXPANDED CUFF
• Type of Device: 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: 16640524
• MDR Text Key: 312285510
• Report Number: 2135147-2023-01398
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734053884
• UDI-Public: 05414734053884
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

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
• Device Operator: Health Professional
• Device Model Number: 21AECJ-502
• Device Catalogue Number: 21AECJ-502
• Device Lot Number: C00002223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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; Other