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

Catalog Number PRT-NG-35

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

Patient Problems Dyspnea (1816); Fatigue (1849); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/19/2022

Event Type  Injury  

Event Description

Clinical study patient id: (b)(4).It was reported that on 06 june 2022, a 35mm navitor titan valve was successfully implanted.On (b)(6) 2022, it was confirmed via an transesophageal echocardiogram that the patient's ejection fraction had decrease to 41% from a previously taken ejection fraction of 50%.The patient reported experiencing fatigue and dyspnea when exerted.The decision was made to upgrade the patient from a single chamber permanent pacemaker to a bi-ventricular permanent pacemaker.The patient was discharged at the time of report and prescribed a regimen of eliquis.

Manufacturer Narrative

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

Manufacturer Narrative

An event of fatigue and dyspnea was reported.A return 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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Subsequent to the previously filed report, additional information was received: it that the upgrade of the patient's single chamber permanent pacemaker to a bi-ventricular pacemaker was not considered an emergency to prevent permanent impairment or death.The 35mm navitor titan valve functioning as intended.The patient was discharged home at the time of report.There was no allegation of malfunction against the 35mm navitor titan valve or procedure.

• 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: 15670165
• MDR Text Key: 302400385
• Report Number: 2135147-2022-01791
• Device Sequence Number: 1
• Product Code: NPT
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRT-NG-35
• Device Lot Number: 8195621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White