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

Catalog Number PRT-NG-35

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problems Atrial Fibrillation (1729); Heart Block (4444)

Event Date 11/14/2022

Event Type  Injury  

Event Description

Clinical information: (b)(4) - portico ng approval study, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 35mm portico ng/navitor titan valve was successfully implanted at final non-coronary cusp depth of 5.81mm and a final left coronary cusp depth of 6.21mm.It was noted via a post-implant electrocardiogram, that the patient developed a left bundle branch block.The 35mm portico ng/navitor titan valve had not been re-sheathed during procedure.There was pacing done during procedure for valve stabilization.Transesophageal echocardiogram revealed that there was no perivalvular leak post-implant.There was no treatment required/performed.The patient was kept in hospital for monitoring of their heart rhythm.On (b)(6) 2022, it was noted that the patient's left bundle branch block developed into first degree atrioventricular block.Again there was no intervention performed/required.The patient was sent home with a 30 day monitor.The patient's at home sotalol medication was discontinued.

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.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 the labeling design or manufacturing of the device.

Event Description

Subsequent to the previously filed report, additional information was received that a pre-operative electrocardiogram showed that the patient present with sinus bradycardia, heart rate of 56 beats per minute.There had been no difficulty experienced implanting the 35mm portico ng/navitor titan valve.The patient had remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.The 35mm portico ng/navitor titan valve remains implanted.There is no intervention planned/required to treat the patient's heart block.On (b)(6) 2022, the patient developed atrial fibrillation while in cardiac rehabilitation.The atrial fibrillation was accompanied by rapid rates with a left bundle baseline, detected via an electrocardiogram.The decision was made to send the patient to the emergency room to be converted back to a normal sinus rhythm.The patient did not experience any other symptoms and was started on a regimen of 25mg of lopressor.The patient was discharged at the time of report and will have a follow up with cardiology later on.The cause of the patient developing a heart block is believed to be from implanting the 35mm portico ng/navitor titan valve.There was no allegation of malfunction against the abbott device or procedure.

• 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: 15924671
• MDR Text Key: 304901867
• Report Number: 2135147-2022-02353
• Device Sequence Number: 1
• Product Code: NPT
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRT-NG-35
• Device Lot Number: 8604834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White