MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DS

Model Number FNAV-DS-SM

Device Problems Difficult to Insert (1316); Use of Device Problem (1670)

Patient Problem Vascular Dissection (3160)

Event Date 09/29/2022

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 25mm navitor valve was chosen for implant using a small flexnav delivery system during a transcatheter aortic valve implantation procedure.A subclavian artery approach was performed.A 14f non-abbott introducer sheath was used.When trying to insert the flexnav delivery system, the gap between the nose cone and the valve capsule caused resistance.It was determined that insertion of the delivery system into the vessel was not possible.There was also resistance when inserting the 14f non-abbott sheath due to the gap between the dilator and the sheath.Since the flexnav delivery system could not be inserted into the vessel, it was combined with a larger 16f non-abbott introducer sheath, but the attempt to insert the delivery system was unsuccessful.Therefore, an 18f non-abbott introducer sheath was inserted with some noted resistance.The flexnav delivery system was then advanced into the sheath, and the delivery and implantation of the valve was successful.When the 18f non-abbott introducer sheath was removed, dissection near the puncture site was noted using digital subtraction angiography (dsa) imaging.The wire had been removed at the time of imaging, so the wire was re-crossed to the dissected portion, and two non-abbott stents were placed from the left subclavian puncture to the bifurcation of the aortic arch.It was reported that the valsava diameter was 28mm, height of valsava was 17.9mm, the annulus circumference was 66.8 mm, and the diameter of ascending aorta was 29.4 mm.The aortic annulus diameter was 21.4 mm, the aortic perimeter was 66.8 mm, and the aortic area was 344.9 mm^2.The patient was reported as stable.

Event Description

N/a.

Manufacturer Narrative

An event of difficulty to insert the delivery system into the vasculature was reported.A returned device assessment could not be performed as the device was not returned for analysis.However, one photo was received from the field which appeared to show ct imaging.Based on the information received, the cause of the reported incident could not be conclusively determined.Na.

• Brand Name: FLEXNAV DS
• Type of Device: FLEXNAV DS
• 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: 15692482
• MDR Text Key: 302679067
• Report Number: 2135147-2022-01844
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: 05415067031372
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FNAV-DS-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 8498751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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: 14F GORE DRYSEAL INTRODUCER SHEATH.; 16F MEDIKIT INTRODUCER SHEATH.; 18F MEDTRONIC SENTRANT INTRODUCER SHEATH.; NAVITOR VALVE, NVTR-25, 19288536.
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 52 KG