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

Catalog Number FNAV-DS-LG

Device Problems Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 27mm navitor valve was chosen to be implanted utilizing a large flexnav delivery system.The patient presented with extreme femoral artery calcification.When attempting to advance through the calcified area, the valve capsule of the delivery system developed fissures and enlargement.The device was removed from the patient intact.A replacement flexnav delivery system was used with the same 27mm navitor valve to complete the procedure.There were no patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout the procedure.The patient was reported to be stable.

Manufacturer Narrative

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

Manufacturer Narrative

An event of the valve capsule of the delivery system developed fissures and enlargement when advancing through patient was reported.A returned device assessment could not be performed as the device 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.Three images from field appeared to show flared and slightly kinked valve capsule having in blood like substance on the nose cone.Based on the information received, the patient had extreme femoral artery calcification which may have contributed to the reported advancement difficulty.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 18241641
• MDR Text Key: 329439749
• Report Number: 2135147-2023-05266
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: 05415067031389
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/21/2023

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: 8926893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• 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 Sex: Female