MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number NVTR-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bradycardia (1751)

Event Date 12/28/2022

Event Type  Injury  

Event Description

It was reported that on(b)(6) 2023, a 25mm navitor valve was selected for an implant.There was no calcification extending beneath the aortic annular plane in the interventricular septum.During the procedure, before the navitor was placed in the aortic valve (during pre balloon aortic valvuloplasty (bav)), there was a tendency for bradycardia.After the navitor was implanted, the patient was reported to be in stable condition.On (b)(6).2023, the patient developed bradycardia and a pacemaker was implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

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

Manufacturer Narrative

An event of atrioventricular block and a pacemaker implant was implanted was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the available information, the cause of the reported event could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.

• Brand Name: NAVITOR
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16448609
• MDR Text Key: 310319837
• Report Number: 2135147-2023-00711
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: 05415067031587
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190023
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 8514428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 45 KG