MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. NAVITOR TAVI VALVE, 25 MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number NVTR-25

Device Problems Backflow (1064); Incomplete Coaptation (2507)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that on (b)(6) 2021, a 25mm navitor valve was implanted with no reported implant complications.After deployment and post-dilation with a 23mm balloon, moderate central aortic valve insufficiency was observed.The user alleged a potential leaflet immobility or sticking towards the stent-frame as the cause of the insufficiency.A second post-dilation was performed, however the aortic insufficiency (ai) persisted.The physician elected to await "one or two days to do a tee for further examination." no further intervention was warranted.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of "moderate central aortic valve insufficiency" and "potential leaflet immobility or sticking towards the stent-frame" was reported.A more comprehensive assessment could not be performed as the device remains implanted 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.

• Brand Name: NAVITOR TAVI VALVE, 25 MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13003217
• MDR Text Key: 285085753
• Report Number: 3007113487-2021-00104
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NVTR-25
• Device Lot Number: 7958170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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
• Patient Age: 82 YR
• Patient Sex: Female