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

Catalog Number FNAV-DS-SM

Device Problem Difficult to Advance (2920)

Patient Problems Stroke/CVA (1770); Cognitive Changes (2551); Thrombocytopenia (4431)

Event Date 01/29/2024

Event Type  Death  

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) 2024, a 27mm navitor valve was chosen for implantation into a bicuspid aortic valve anatomy type 1 utilizing a flexnav delivery system.The patient presented with severe calicum score of 6251, severe aortic stenosis, and horizontal aorta.The valve was pre-dilated with a 18mm balloon ((balloon annular valvuloplasty (bav)).A guidewire and a buddy wire was needed to traverse the difficult horizontal aorta.At deployment, the navitor was placed at 5mm in left coronary cusp (lcc), 4mm in non-coronary cusp (ncc), and 5mm in right coronary cusp (rcc).After full release, the 27mm navitor was at 5mm in lcc, 4 mm in ncc and 6mm in rcc.No tension in delivery system during deployment.The valve looked constrained due to the severe calcification and moderate perivalvular leak (pvl) was present.Post-bav dilatation was performed with a 20mm balloon.Once the balloon was removed, the navitor migrated supra annular.There was no blocking of coronary arteries and no clinical signs or symptoms due to the migration.The valve was snared and placed 5 cm above the aortic annulus.A replacement 25mm navitor (serial:(b)(6)) was then implanted.Due to valve under expansion, post-bav dilatation was performed with 20mm balloon seven times.Gradient of 13mmhg.The procedure ended with mild pvl present on echocardiogram.There was reportedly a delay that resulted in no patient effects.Post procedure, after removal from general anesthesia, the patient was confused and having trouble waking up.Suffered a.Computerized tomography scan was taken which also revealed multi territory stroke as well as aortic dissection in the ascending aorta.It was thought this dissection was due to snaring the migrated valve along with difficulty crossing the horizontal aorta with both flexnav delivery systems.It was thought the stroke was related to both valves causing debris embolization, multiple balloon valvuloplasty's, and difficulty crossing aortic valve due to horizontal angle with both flexnav delivery systems.The patient was not a surgical candidate so they were management medically.Patient had thrombocytopenia which increased risk of bleeding.The patient died three days post-procedure.The cause of death was due to the aortic dissection and stroke.

Manufacturer Narrative

An event of difficult advancement through patient anatomy and death 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 no related incidents were found for the lot.Information from the field indicated that there was difficulty deploying and retracting the valve during the procedure due to the patient's horizontal aortic angle.Post-procedure, the patient was diagnosed with a multi territory stroke as well as aortic dissection in the ascending aorta.It was thought this dissection was due to snaring the migrated valve along with difficulty crossing the horizontal aorta with both flexnav delivery systems.It was thought the stroke was related to both valves causing debris embolization, multiple balloon valvuloplasty's, and difficulty crossing the aortic valve due to horizontal angle with both flexnav delivery systems.The patient died three days post-procedure.The cause of death was due to the aortic dissection and stroke.The event was further reviewed by an abbott senior director of medical affairs.Based on available information, the reported event appears to be related to a combination of procedural conditions (multiple balloon valvuloplasties, decision to snare other valve, etc.) and patient condition (severe calcification, horizontal aortic valve angle).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: 18841390
• MDR Text Key: 336944147
• Report Number: 2135147-2024-01005
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: 05415067031372
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 9008369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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 Outcome(s): Death
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 80 KG