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

Catalog Number PRT-NG-29

Device Problems Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bradycardia (1751); Pseudoaneurysm (2605); Heart Block (4444); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

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 29mm portico ng was selected for implant using a large flexnav delivery system.The size of the annulus was 29mm.Predilatation was performed with a 23mm balloon.It was noted that there was severe calcification.During the procedure, it was noted that the device did not take the correct shape, so another re-sheathed and predilatation was performed.Another implant attempt with the valve was performed and was successful.Shortly after, the valve embolized and moved into the ascending aorta.The device was snared and moved into the aortic arch.A new 29mm portico ng was implanted to resolve the event.The patient is reported to be stable.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

Manufacturer Narrative

An event of valve not taking proper shape, device embolization, left femoral pseudoaneurysm, left bundle branch block and bradycardia 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 information received, the cause of the reported incident could not be conclusively determined.Please note that, per the instructions for use, "once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage."clinical code 4582 was removed.

Event Description

Subsequent to the previously filed report, additional information was received that: it was reported that on (b)(6) 2022, after the procedure prior to discharge the patient experience a left bundle branch block.The heart block was found via electrocardiogram.The heart block resolved without intervention.On (b)(6) 2022, it was reported that the patient experienced a left femoral pseudoaneurysm.The pseudoaneurysm resolved without intervention.It was then reported that on (b)(6) 2022 the patient presented to the emergency room for bradycardia.No treatment was given and no intervention was done.On (b)(6) 2022 the patient was admitted to a different hospital for bradycardia and heart failure.The heart failure is a pre-existing condition.There was no treatment administered.Bradycardia resolved, heart failure ongoing.No allegation against the abbott device.The patient is reported to be discharged and stable.No additional information was provided.

• 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: 15539963
• MDR Text Key: 301152630
• Report Number: 2135147-2022-01478
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRT-NG-29
• Device Lot Number: 8130462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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: DELIVERY SYSTEM, FN-DS-LG-IDE, 19014091
• Patient Outcome(s): Required Intervention