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

Model Number NVTR-27

Device Problems Difficult to Fold, Unfold or Collapse (1254); Perivalvular Leak (1457)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 12/02/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022, a 27mm navitor valve was chosen for implant using a large flexnav delivery system.The patient was intubated, and femoral access was obtained without incident.The patient's perimeter was sized as 77mm.A pre-dilatation was performed using a 22mm non-abbott balloon.The delivery system was inserted into the patient with the device.During the initial valve deployment, the valve was deployed at 80% and it was noted the device was too deep in the annulus to continue.The device was recaptured.It was noted that the patient had a heavily calcified annulus with left ventricular outflow tract calcium.During the second deployment attempt, the valve was deployed at good height.However, the valve appeared constrained on the fluoroscopy imaging.At this time, it was noted that the patient was in ventricular fibrillation (vf).A 200j shock was delivered by the treating anesthetist and adrenaline was administered.The valve was the deployed at an optimal depth of 4mm at the left coronary cusp and 5mm at the non-coronary cusp.The patient went into vf four more times.It was attempted to stabilize the patient with defibrillation shocks, adrenaline and cardiopulmonary resuscitation (cpr).Patient was stabilized into a paced rhythm.It was noted on fluoroscopy and on the transesophageal echocardiogram (tee) following the aortogram that the patient had moderate posterior paravalvular leak.A 23mm crystal balloon was used to perform a post dilatation balloon valvuloplasty.During the post dilatation when the balloon was being deflated, the patient went back in vf, a 200j defibrillation shock was applied and adrenaline given with cpr, patient didn't revert to normal rhythm and remained in vf.An additional 200j defibrillation shock was performed with adrenaline and cpr administered.The patient was stabilized and remained in a paced rhythm for the duration of the case.It was noted the post balloon valvuloplasty had improved the leak and that the valve had opened fully.A gradient of 9mmhg was noted as the final measurement and a mild leak was noted by the echocardiologist.The patient was discharged home at the time of this report.

Manufacturer Narrative

An event of the moderate posterior paravalvular leak and ventricular 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, including specification for radial force.Based on the information received, the 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: 16039959
• MDR Text Key: 306066601
• Report Number: 2135147-2022-02698
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: 05415067031594
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 8496159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male