MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Catalog Number FNAV-DS-LG

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

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 large flexnav delivery system.During deployment of the valve, the patient¿s blood pressure was observed to drop.Subsequently, the system was removed from the anatomy.Reinsertion was attempted after flushing the blood from all flush ports as much as possible, but it was difficult to insert due to a split of the tip of the valve capsule.The patient had a mild tortuous anatomy.As adhesion of the thrombus was recognized when the bioprosthetic valve was removed, the system was changed including valve and delivery system.During advancement of flexnav, the physician attempted to deliver the device while pushing the non-abbott guidewire excessively.A strong resistance was felt when passing through the aortic arch.It was suspected that the apex was perforated at that time.Pericardial effusion was observed, requiring pericardiocentesis.This has led to cardiac tamponade.This was attributed to the guidewire.After the pericardial drainage was performed, the chest was opened, then arrest hemorrhage.Shifted to surgical aortic valve replacement (avr).The patient is reported to be still on percutaneous cardiopulmonary support (pcps) as of (b)(6) 2023.This has reportedly caused a clinically significant delay.

Manufacturer Narrative

An event of difficult insertion and material deformation was reported.Information from the field indicated that reinsertion was difficult due to a flared valve capsule tip.Based on available information, the reported difficult insertion appears to be related to the flared valve capsule tip.However, a root cause for the flared valve capsule tip could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: FLEXNAV DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18366815
• MDR Text Key: 331361056
• Report Number: 2135147-2023-05612
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: 05415067031389
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 8942148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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 Age: 86 YR
• Patient Sex: Male
• Patient Weight: 49 KG