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

Catalog Number PRT-NG-29

Device Problem Malposition of Device (2616)

Patient Problem Atrial Fibrillation (1729)

Event Date 01/11/2023

Event Type  Injury  

Event Description

Crd_1003 - vantage ide study, eu3520 - 398.(b)(4).It was reported that on (b)(6) 2023, a navitor 29mm valve was selected for an implant.The final implant depth was 8mm and no calcification extending beneath the aortic annular plane in the interventricular septum.During the procedure, device was successfully implanted in the patient.On (b)(6) 2023, it was reported that the patient had left bundle branch block.On (b)(6) 2023, the patient had beta-blockers administered/adjusted and cardioversion performed.On (b)(6) 2023, antiarrhythmic medication was administered/adjusted.The patient does not have a history of conduction disturbances and did not required a pacemaker implantation.The patient was reported to be in stable condition.

Manufacturer Narrative

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

Manufacturer Narrative

An event of a left bundle branch block and atrial fibrillation 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.Possible contributing factors to arrhythmia after a portico valve implant include patient conditions, such as pre-existing arrhythmia, anatomical factors, such as calcification extending beneath the aortic annular plane in the interventricular septum, and the depth of implant of the device.Information from the field indicated that the valve was implanted at a 8mm which is deeper than the recommended depth.Information from the field indicated that there wasn't calcification extending beneath the aortic annular plane in the interventricular septum.Based on the available information, the root cause of the reported event was the deeper implant depth which could have contributed to the reported events.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note per instructions for use,artmt600132358 rev.D , to minimize the likelihood of permanent pacemaker implantation (ppi): a) maintain implant depth of 3 mm, and b) limit manipulations across the lvotna.

Event Description

(b)(6) - vantage ide study, (b)(6).It was reported that on (b)(6) 2023, a navitor 29mm valve was selected for an implant.The final implant depth was 8mm and no calcification extending beneath the aortic annular plane in the interventricular septum.During the procedure, device was successfully implanted in the patient.On the same day, it was reported that the patient had left bundle branch block.On (b)(6) 2023, the patient had beta-blockers administered/adjusted and cardioversion performed.On (b)(6) 2023, antiarrhythmic medication was administered/adjusted.The patient does not have a history of conduction disturbances and did not required a pacemaker implantation.Patient stable.

• Brand Name: NAVITOR
• 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: 16312841
• MDR Text Key: 308954448
• Report Number: 2135147-2023-00425
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRT-NG-29
• Device Lot Number: 8191439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Hispanic
• Patient Race: White