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

Catalog Number PRT-NG-25

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

Patient Problems Atrial Fibrillation (1729); Fever (1858); Unspecified Infection (1930); Heart Block (4444)

Event Date 10/17/2022

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 study: (b)(4)- vantage ide study - clinical name, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 25mm portico valve was selected for implant using a small flexnav delivery system.During the procedure, after pre-balloon valvuloplasty and after the abbott device made contact, the patient experienced left bundle branch block.No intervention was done to treat the heart block.The patient has sinus rhythm.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.On (b)(6) 2022, the patient developed a fever and was diagnosed with an infection.Antibiotics were prescribed.It is believed that the infection is not related to the implanted device.On (b)(6)2022, electrocardiogram (ecg) showed that the patient was having intermediate atrial flutter.The patient was started on anticoagulant as treatment.On (b)(6) 2022, the patient was reported to be discharged.A healthcare professional has stated that they believe the patient has not experienced adverse health consequences due to the performance of the product.No additional information was provided.

Event Description

Clinical study: (b)(6) - vantage ide study - clinical name, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 25mm portico valve was selected for implant using a small flexnav delivery system.During the procedure, after pre-balloon valvuloplasty and after the abbott device made contact, the patient experienced left bundle branch block.No intervention was done to treat the heart block.The patient has sinus rhythm.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.On (b)(6) 2022, the patient developed a fever and was diagnosed with an infection.Antibiotics were prescribed.It is believed that the infection is not related to the implanted device.On (b)(6) 2022, electrocardiogram (ecg) showed that the patient was having intermediate atrial flutter.The patient was started on anticoagulant as treatment.On (b)(6) 2022, the patient was reported to be discharged.A healthcare professional has stated that they believe the patient has not experienced adverse health consequences due to the performance of the product.Subsequent to the previously filed report, additional information was received that after the patient was diagnosed with a fever they were administered tazobactan and piperacillin.The patients fever was reduced.

Manufacturer Narrative

An event of left bundle branch block, fever and intermediate atrial flutter was reported.A returned device assessment could not be performed as the device 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 incident could not be conclusively determined.

• 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: 15808852
• MDR Text Key: 303849649
• Report Number: 2135147-2022-02076
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRT-NG-25
• Device Lot Number: 8405455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2022
• 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): Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 90 KG