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

Model Number NVTR-27

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 03/08/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2023, a 27mm navitor valve was chosen for implant using a flexnav delivery system for a transcatheter aortic valve implantation (tavi).Heparin was administered during the procedure.The safari xs guidewire was inserted, and a pre-implant balloon aortic valvuloplasty was performed.The dryseal introducer sheath was replaced with the flexnav integrated sheath and was attempted to be inserted into the vessel.There was difficulty inserting the sheath to catch the correct position of the puncture site.The flexnav integrated sheath was replaced with a lunderquist guidewire, and a 20f dryseal introducer sheath was inserted.The safari xs guidewire was inserted again, and the integrated sheath was able to be inserted into the vessel.On first deployment of the valve, it was slightly deeper than the ideal position, so the valve was re-sheathed.During the second deployment of the valve, it was confirmed to be at 4-5mm, which was the ideal depth.However, because the valve followed too closely to the greater curvature and because there was slight tension at the upper side of the stent, the decision was made to re-sheath the valve again.After the third deployment of the valve, the valve was at 6-7mm in depth, which was too deep.The valve was re-sheathed a third time, and there was decrease in the patient's blood pressure.A vasopressor was administered, but the blood pressure did not rise as expected.A pericardial effusion with cardiac tamponade was confirmed, and an emergent thoracotomy was conducted.Patient was placed on bypass.Cardiac perforation was confirmed in multiple places in the apex and the posterior wall.The punctured sites were attempted to be sutured, but the cardiac muscle was too fragile to tolerate the procedure.Bleeding was difficult to be controlled.The damage to the left ventricle was broad, and the patient was in an unstable condition.The tavi procedure was aborted and converted to a surgical aortic valve replacement.Hemostasis and reconstruction of the left ventricle were achieved, and an aortic valve replacement and replacement of the ascending aorta were performed.The patient was placed on extracorporeal membrane oxygenation (ecmo) and transferred to the intensive care unit (icu).A blood transfusion was required.The physician was reported to believe that this adverse event was related to the manipulation of the safari guidewire and not related to the navitor valve or flexnav delivery system.

Manufacturer Narrative

An event of pericardial effusion and cardiac tamponade was reported.The device was returned to abbott for investigation and was found to have limited mobility leaflet wise when analyzed under non-physiological conditions consistent with leaflet dehydration due to multiple deployment attempts.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 reported incident is consistent with damage suffered as a result of multiple guidewire manipulations and re-sheaths of the valve.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note that per the instruction for use, "implantation precautions: do not re-sheath the valve more than two times prior to final valve release.Additional re-sheath attempts may compromise product performance."h6 medical device problem code: code 1670 removed.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16659868
• MDR Text Key: 312497751
• Report Number: 2135147-2023-01444
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: 05415067031594
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• 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: 8543477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• 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
• Treatment: FLEXNAV DELIVERY SYSTEM, FNAV-DS-LG.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Female