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

Model Number	PRT-29
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 01 june 2023, a 29mm portico valve (19304666) was chosen for implant during a transcatheter aortic valve implantation using flexnav delivery system.The native valve perimeter was measured as 81.7mm.A pre-dilatation balloon valvuloplasty was performed with a 22mm non-compliant balloon.There was severe calcium present with extension of calcification to interventricular septum, below the annulus.The starting implant depth of the valve was 4mm.For the final implant depth at release, the valve height was 2mm into the left ventricular outflow tract (lvot).There was no tension in the delivery system at the time of final deployment.The patient did not have a horizontal aorta.After full release of the valve, the valve dislodged from the aortic annulus into the sinus towards the ascending aorta.During the valve migration, the pigtail was at the non-coronary cusp, and the delivery system was in the ascending aorta, and there were no sudden changes in hemodynamics at the time of migration.The migrated valve did not block a coronary artery or arteries, and the valve was not snared or repositioned.Another 29mm portico valve (19331519) was implanted immediately within the first via valve-in-valve procedure.After the replacement valve was implanted, a perivalvular leak was noted.A post-dilatation balloon valvuloplasty was performed, and the perivalvular leak resolved.The patient remained stable throughout the procedure.The patient status was reported as stable.
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 valve migration was reported.Based on the information received, the cause of the reported incident could not be conclusively determined.A returned device assessment could not be performed as the device remains implanted and is 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, including specification for radial force.

• Brand Name: PORTICO 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: 17139880
• Report Number: 2135147-2023-02609
• Device Sequence Number: 17585911
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/21/2023

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: 03/07/2025
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 8402981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLEXNAV DELIVERY SYSTEM, FNAV-DS-LG, 8393533; PORTICO VALVE, PRT-29, 8411785, 19331519
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male