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

Catalog Number NVRO-23

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

Patient Problem Heart Block (4444)

Event Date 03/26/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, a 23mm navitor vision valve was chosen for implantation utilizing a small flexnav delivery system.There was no calcification extending beneath the aortic annular plane in the interventricular septum.The patient had no history of conduction disturbances.Following placement of the valve at a depth of non-coronary cusp (ncc): 4mm and left coronary cusp (lcc): 6mm, the patient developed complete heart block.A temporary pacemaker was placed.The patient was hospitalized for monitoring of rhythm.The following date (b)(6) 2024, a permanent pacemaker was implanted.The patient was reported to be discharged.

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of heart block 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.Information from the field indicated that the valve was implanted at a depth of 4mm non-coronary cusp (ncc) 4mm and 6mm left coronary cusp (lcc).The patient developed complete heart block.There was no calcification extending beneath the aortic annular plane in the interventricular septum.Based on available information, a cause for the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: NAVITOR VISION
• 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: 19136231
• MDR Text Key: 340563375
• Report Number: 2135147-2024-01742
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)260621(10)9141812
• 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,Followup
• Report Date: 05/24/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: NVRO-23
• Device Lot Number: 9141812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2023
• 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
• Treatment: FLEXNAV DELIVERY SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention