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

Catalog Number	NVTR-23
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm navitor valve was selected for implant using a small flexnav delivery system and a small navitor loading system.The patient's aortic angle was less than 45 degrees.There was sufficient calcium to allow anchoring of the valve; the calcium score is unavailable.Pre-dilatation was performed with a 18mm unknown manufacturer balloon; the balloon did not exceed the minimum diameter.The patient's annulus dimensions were as follows: annulus diam: 21mm, area 337.9mm2, perimeter 66mm, lvot 21.3mm the implant depth at 80% was 5mm.The implant depth prior to release was 3mm.The flexnav was in neutral position prior to release and the guidewire was pulled back prior to pulling the flexnav.All 3 tabs were confirmed to have been released.The valve was recaptured once.Post-release, valve migration occurred and the valve migrated towards the aorta; it did not block any arteries.There was no entanglement between the navitor and the flexnav while removing the delivery system.The physician alleged that under-expansion was the cause of migration.The valve was snared to position and a new 23mm navitor valve was implanted via valve-in-valve.Post-dilatation was performed with a 20mm non-abbott balloon.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device migration 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.Based on available information, the caus of reported event could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the a (valve-in-valve) was implanted.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note that per the navitor instructions for use, "once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.Since this did not cause the reported event letter will not be sent.

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• Common Device Name: 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: 20568181
• Report Number: 2135147-2024-05462
• Device Sequence Number: 7460251
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)260816(10)9230928
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2026
• Device Catalogue Number: NVTR-23
• Device Lot Number: 9230928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 67 KG