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

Catalog Number NVTR-27

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 08/29/2022

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 27mm navitor valve was chosen for a transcatheter aortic valve replacement using a flexnav delivery system via subclavian access route.During procedure, the intima of the right subclavian artery was dissected by the nose cone and capsule of the delivery system, which occluded the subclavian artery.After advancing a guidewire from the right radial artery and another guidewire from the right femoral artery to cross the lesioned area, the femoral artery guidewire was pulled through using the snare from the radial artery guidewire.A balloon valvuloplasty pre-dilatation was performed with a non-abbott balloon, diameter of 6mm by length of 40mm.A non-abbott stent, diameter of 7mm by length of 40mm, was implanted.The navitor valve was implanted.A balloon valvuloplasty post-dilatation was performed with a non-abbott balloon, diameter of 6mm by length of 40mm.The dissection was also on the central side of the right common carotid artery, but no additional treatment was performed because of the possibility of occlusion or stenosis of the right common carotid artery.

Manufacturer Narrative

An event of external native interference affecting the expansion of the valve 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 including the valve meeting stent radial force specifications, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.H6 health effect - clinical code: code 4580 removed.

Event Description

It was reported that on (b)(6) 2022, a 27mm navitor valve was chosen for a transcatheter aortic valve replacement using a flexnav delivery system via subclavian access route.During procedure, the intima of the right subclavian artery was dissected by the nose cone and capsule of the delivery system, which occluded the subclavian artery.After advancing a guidewire from the right radial artery and another guidewire from the right femoral artery to cross the lesioned area, the femoral artery guidewire was pulled through using the snare from the radial artery guidewire.A balloon valvuloplasty pre-dilatation was performed with a non-abbott balloon, diameter of 6mm by length of 40mm.A non-abbott stent, diameter of 7mm by length of 40mm, was implanted.The navitor valve was implanted.A balloon valvuloplasty post-dilatation was performed with a non-abbott balloon, diameter of 6mm by length of 40mm.The dissection was also on the central side of the right common carotid artery, but no additional treatment was performed because of the possibility of occlusion or stenosis of the right common carotid artery.Subsequent to the previously filed report, additional information was received that the aortic annulus diameter was 24.2mm.The final implant depth of the valve was in the appropriate position.The right subclavian access route was utilized due to a shaggy aorta, and there was a risk of plaque in both of the patient's inguinal regions.The patient's left subclavian artery had a high risk of vascular complications due to calcification and a narrow lumen, which was why the right subclavian access route was utilized.The micro adjustment wheel was used during loading of the device to close the gap between the valve capsule and the radiopaque tip, and the distal end was exterior and straightened when the micro adjustment wheel was used.Before insertion into the blood vessel, a gap was intentionally created in advance with the nosecone in order to prevent over-capture when inserting the delivery system into the blood vessel.There was strong resistance when the delivery catheter was inserted into the access blood vessel.The intima of the right subclavian artery was dissected by the nose cone and capsule of the delivery system during the insertion of the delivery catheter.It was thought that the dissection did not occur due to the gap between the nose cone and the capsule, but because the capsule exceeded the distal edge of the nosecone, known as over-capture.Once the delivery system was removed from the body, the over-capture was observed.There was sufficient calcium present to allow sealing, but the annular calcium distribution was unknown.There was an external native interference affecting the expansion of the valve, which was why a post-dilatation balloon valvuloplasty was performed after valve deployment.The patient status was unknown.The patient did not have a history of pulmonary hypertension.The patient did not require a blood transfusion.

• 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: 15463222
• MDR Text Key: 300370213
• Report Number: 2135147-2022-01293
• Device Sequence Number: 1
• Product Code: NPT
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NVTR-27
• Device Lot Number: 8465366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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: FLEXNAV DELIVERY SYSTEM, FNAV-DS-LG, (B)(6); NAVITOR VALVE, NVTR-27, (B)(6)
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female