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

Catalog Number PRT-NG-25

Device Problem Off-Label Use (1494)

Patient Problems Bradycardia (1751); Heart Block (4444)

Event Date 04/05/2023

Event Type  Injury  

Event Description

Clinical information: crd_1003 - vantage, patient site id: au4668 - 181, r821501001 it was reported that on (b)(6) 2023, a 25mm navitor valve was implanted using a flexnav delivery system during a transcatheter aortic valve implantation.The procedure was an off-label valve-in-valve procedure where the navitor valve was implanted into a previously implanted 23mm non-abbott valve.The valve was successfully implanted at a depth of 5mm for the non-coronary cusp and 5mm for the left coronary cusp.On (b)(6) 2023, the patient presented to the emergency department with bradycardia.Patient denied any other symptoms.On electrocardiogram (ecg), the patient was in complete heart block.A permanent pacemaker was implanted.On (b)(6) 2023, a transthoracic echocardiogram (tte) was performed, which showed that the valve was stable.The patient status was reported as stable.

Manufacturer Narrative

An event of off-label use, heart block, and bradycardia were reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.The patient's medical history included surgical aortic valve replacement, genitourinary, hyperlipidemia, hypertension, pulmonary hypertension, and intra-ventricular conduction delay.It was unknown if there was calcification extending beneath the aortic annular plane in the interventricular septum.The valve was successfully implanted at a depth of 5mm for the non-coronary cusp and 5mm for the left coronary cusp.Later on, the patient presented to the emergency department with bradycardia.On electrocardiogram (ecg), the patient was in complete heart block.A permanent pacemaker was implanted.The patient status was reported as stable.Based on the information received, the cause of the reported incident could not be conclusively determined.The reported off-label use appears to be related to user as the user implanted the navitor valve into a previously implanted 23mm non-abbott valve.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18685544
• MDR Text Key: 335198420
• Report Number: 2135147-2024-00603
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRT-NG-25
• Device Lot Number: 8130459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White