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

Catalog Number NVTR-29

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Block (4444)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Clinical information: (b)(6) - vista registry, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 29mm navitor valve was successfully implanted in a patient.On 01 march 2024, it was noted that the patient developed a complete heart block.The decision was made to implant a dual chamber permanent pacemaker.

Event Description

Clinical information: (b)(6) - vista registry, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 29mm navitor valve was successfully implanted in a patient.On (b)(6) 2024, it was noted that the patient developed a complete heart block.The decision was made to implant a dual chamber permanent pacemaker.Subsequent to the previously filed report, additional information was received that there was no difficulty implanting the 29mm navitor valve.The final non-coronary cusp implant depth was 6mm.There was no calcification extending beneath the aortic annular plane in the interventricular septum.The patient did not have a prolonged hospital stay for monitoring of rhythm.The cause of the complete heart block is attributed to the 29mm navitor valve.However, there is no allegation of malfunction against the abbott device or procedure.The patient was discharged at the time of report.

Manufacturer Narrative

An event of device malposition and 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 implant depth was 6mm from the non-coronary cusp (deeper than the recommended 3mm) and 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.Correction.H6 medical device problem code: code 2993 removed.

• 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: 19160583
• MDR Text Key: 340794855
• Report Number: 2135147-2024-01801
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: (01)05415067031600(17)260315(10)8980400
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NVTR-29
• Device Lot Number: 8980400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 80 KG