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

Catalog Number NVRO-27

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

Patient Problem Heart Block (4444)

Event Date 04/03/2024

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 a 27mm navitor vision valve was selected for implant on 03 april 2024 using a large flexnav delivery system.The patient had a past medical history of a right bundle branch block (rbbb).There was no calcification extending beneath the aortic annular plane in the interventricular septum.A pre-implantation balloon-aortic valvuloplasty (bav) was performed with a non-abbott device.The patient went into complete heart block.The device was implanted.The final implant depth was 4mm.The heart block persisted.A permanent pacemaker was implanted.The patient status was stable.

Event Description

It was reported that a 27mm navitor vision valve was selected for implant on (b)(6) 2024 using a large flexnav delivery system.The patient had a past medical history of a right bundle branch block (rbbb).There was no calcification extending beneath the aortic annular plane in the interventricular septum.A pre-implantation balloon-aortic valvuloplasty (bav) was performed with a non-abbott device.The patient went into complete heart block.The device was implanted.The final implant depth was 4mm.The heart block persisted.A permanent pacemaker was implanted.The patient status was stable.

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 patient had a past medical history of a right bundle branch block (rbbb).There was no calcification extending beneath the aortic annular plane in the interventricular septum.A pre-implantation balloon-aortic valvuloplasty (bav) was performed with a non-abbott device (pre-bav caused complete heart block).The patient went into complete heart block.The device was implanted with the final implant depth was 4mm (deeper than 3mm depth of implant of the device).The heart block persisted.A permanent pacemaker was implanted.Based on the information available, the cause of the reported event appears to be related to procedural conditions (pre-bav).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: 19196308
• MDR Text Key: 341239443
• Report Number: 2135147-2024-01869
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067045799
• UDI-Public: (01)05415067045799(17)260718(10)9185108
• 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: 05/10/2024

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-27
• Device Lot Number: 9185108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2023
• 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, FNAV-DS-LG
• Patient Outcome(s): Required Intervention