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

Catalog Number PRT-NG-29

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

Patient Problems Atrial Fibrillation (1729); Renal Failure (2041); Heart Block (4444)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Crd_1003 - vantage ide study, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 29mm portico ng valve was implanted.The patient's baseline rhythm is sinus rhythm with first degree atrioventricular block.During the procedure, during valve implantation, the patient experienced 3rd degree heart block and new onset atrial fibrillation.On (b)(6) 2023, a permanent pacemaker was implanted to treat the heart block.On 03 february 2023, the patient was diagnosed with acute kidney failure, however no treatment was required.On (b)(6) 2023, the patient was discharged.

Manufacturer Narrative

An event of third degree heart block, acute kidney failure and new onset 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.Based on the available information, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

Crd_1003 - vantage ide study, patient site id: eu3571 - (b)(6).It was reported that on (b)(6) 2023, a 29mm portico ng was implanted.The patient's baseline rhythm is sinus rhythm with first degree atrioventricular block.During the procedure, during valve implantation, the patient experienced 3rd degree heart block and new onset atrial fibrillation.On (b)(6) 2023, a permanent pacemaker was implanted to treat the heart block.On (b)(6) 2023, the patient was diagnosed with acute kidney failure, however no treatment was required.On (b)(6) 2023, the patient was discharged.

• 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: 16438595
• MDR Text Key: 310227051
• Report Number: 2135147-2023-00667
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 05/09/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRT-NG-29
• Device Lot Number: 19353986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 81 KG