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

Model Number NVTR-27

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

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) 2023, a 27mm navitor was selected for an implanted.The starting implant depth was 3mm.The sizing of the annular dimensions was: 18.7 x 27.8 (min x max), perimeter derived 23.8mm.During the procedure, due to heavy calcification of native valve and hypertrophic ventricle, the device migrated and was snared into ascending aorta.The physician aware of the ifu warning against snaring the valve.No hypertensive spike or pulmonary hypertensive episode was detected when the device migrated.A non-abbott device was selected and implanted successfully.The patient was reported to be in stable condition.No additional information was provided.

Manufacturer Narrative

An event of device migration was 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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Information from the field also indicated that due to heavy calcification of native valve and hypertrophic ventricle the device migrated.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use."post-implantation precautions: once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.".

• 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: 16526442
• MDR Text Key: 311136313
• Report Number: 2135147-2023-01136
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: 05415067031594
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 8540680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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): Required Intervention