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

Catalog Number	PRT-23
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Perivalvular Leak (1457)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of paravalvular leak and device migration was reported.Information from the field indicated that the valve appears to be correctly sized based on provided dimensions, the implant depth at deployment was 3mm from the non-coronary cusp, there was sufficient calcium to allow seating in the opinion of the physician, and there were no deployment or retraction difficulties.Additionally, it was noted that the migration was due to the post dilatation performed.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 reported device migration is due to procedural conditions (result of post dilatation).A root cause for the reported paravalvular leak could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2023, a 23mm portico valve was chosen for implant, using small flexnav delivery system.The patient was presented with severe aortic stenosis.The annular dimensions of the native valve were measured to be 63.1 mm annulus perimeter, 20.1mm perimeter derived diameter, 312.3 mmsq area.Pre-dilatation of the native valve was done with a 18mm non-abbott balloon.After two attempts of recapture and deployment, the portico valve was deployed at a starting implant depth of approximately 3mm and a final implant depth of about 1-2mm.In the physician¿s opinion, there was a sufficient calcium to allow anchoring of the device.Patient had moderate paravalvular leak (pvl) and mean pressure gradient of 12mmhg, hence post-dilatation was performed with 20mm non-abbott balloon.Due to post-dilatation, the valve migrated to zero depth at annulus.The gradients and aortic regurgitation (ar) were reduced; however, after a few minutes, the valve embolized and moved to -1 above the aortic annulus.A second 23mm portico valve had to be deployed as the patient experienced severe ar due to valve embolization.This issue reportedly caused a clinically significant delay.The patient is reported to be stable.

• 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: 18378972
• Report Number: 2135147-2023-05661
• Device Sequence Number: 7711093
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 12/21/2023

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: 08/29/2024
• Device Catalogue Number: PRT-23
• Device Lot Number: 8235844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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: SMALL FLEXNAV DELIVERY SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 50 KG