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

Catalog Number FNAV-DS-SM

Device Problems Retraction Problem (1536); Material Deformation (2976)

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

Event Date 03/05/2024

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 a 25mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2024 using a small flexnav delivery system.During the procedure it was observed that the device could not be re-sheathed due to the pigtail catheter getting stuck in the valve capsule.It was noted that due to the calcium on the leaflets the pigtail catheter was unable to be placed at the bottom of the non-coronary cusp (ncc) and kept moving up.While re-sheathing the valve the pigtail catheter got caught on the valve strut and was pulled into the capsule.The device was deployed at 80% to remove the pigtail catheter.It was noted that upon removal of the catheter the device could not be completely re-sheathed due to the capsule deforming into an accordion shape.The device and delivery system were removed from the patient and replaced with a new 25mm navitor transcatheter aortic valve and small flexnav delivery system.The device was implanted.The patient did not present with any clinical signs or symptoms.The patient status was stable.

Manufacturer Narrative

An event of a retraction problem and material deformation was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The complaint database was reviewed, and there does not appear to be an indication of a lot specific product issue.Information from the field indicated that the device could not be re-sheathed due to the pigtail catheter getting stuck in the valve capsule.It was noted that due to the calcium on the leaflets the pigtail catheter was unable to be placed at the bottom of the non-coronary cusp (ncc) and kept moving up.While re-sheathing the valve the pigtail catheter got caught on the valve strut and was pulled into the capsule.The device was deployed at 80% to remove the pigtail catheter.It was noted that upon removal of the catheter the device could not be completely re-sheathed due to the capsule deforming into an accordion shape.Based on all available information, the reported event appears to be related to a combination of patient condition (calcified leaflets) and procedural conditions (calcified leaflets affected pigtail catheter placement, pigtail catheter pulled into capsule, and capsule deformation as a result of the pigtail catheter pulled into capsule).There is no indication of a product quality issue with regards 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: 19013250
• MDR Text Key: 339208555
• Report Number: 2135147-2024-01419
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)240930(10)8703317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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-SM
• Device Lot Number: 8703317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2022
• 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: 25MM NAV TRANS AORT VAL[NVTR-25, SERIAL: (B)(6)]
• Patient Age: 70 YR
• Patient Sex: Female