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

Catalog Number NVTR-25

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

Patient Problems Non specific EKG/ECG Changes (1817); Obstruction/Occlusion (2422)

Event Date 04/02/2024

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 on (b)(6) 2024, a 25mm navitor valve was chosen for a procedure.The annular dimension of the native valve were perimeter 68mm and area of 356mm^2.The valve was implanted at a depth of 2mm at non-coronary cusp and 1mm at left coronary cusp.One to one half hours after the procedure, the patient had electrocardiogram (ekg) changes associated with hemodynamic instability indicating a right coronary artery (rca) occlusion.The physician mentioned the valve appeared in place and no migration was noted.The cause of occlusion was felt to be secondary to small piece of calcium vs possible piece of balloon secondary to balloon rupture during post balloon aortic valvuloplasty (bav).The patient was placed on extracorporeal membrane oxygenation (ecmo) and stent was placed in rca.After the procedure, the patient was removed form ecmo.The patient was reported stable.

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• 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: 19194116
• MDR Text Key: 341172221
• Report Number: 2135147-2024-01862
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)251107(10)8776631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NVTR-25
• Device Lot Number: 8776631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2022
• 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): Hospitalization; Required Intervention