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

Catalog Number	PRT-23
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 25mm portico valve was selected for an implant using a small flexnav delivery system.The sizing of the annular dimensions of the native valve was: annulus diameter 22.2mm area 381.6mm2, perimeter 69.9.The patient did not have a horizontal aorta.A pre-dilatation balloon aortic valvuloplasty (bav) performed with a non-abbott device.During the procedure, after the full deployment of portico, the physician confirmed 3 retained tabs was free and pulled back flexnav, however portico valve was moved to the ascending aorta with a final implant depth of 4mm.The patient did not have a hypertensive spike or pulmonary hypertensive episode at the time of migration.The valve moved over the annulus, the physician snared over the ostiums in order to avoid coronary occlusion.The physician aware of the ifu warning against snaring the valve.It was necessary to use a second 23mm portico valve in order to guarantee the successes of the procedure.A post-dilatation performed due to paravalvular leak (pvl) post implant of the second valve due to two points of calcium over the annulus.After 2 days, the leak was trace on echocardiogram.The patient is stable, no additional information was provided.
Additional Manufacturer Narrative
An event of the paravalvular leak (pvl) after implant was reported.Information from the field indicated that there were two points of calcification over the annulus that caused the pvl and that there were no deployment difficulties.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.Based on available information, the root cause of the paravalvular leak appears to be the calcification over the annulus.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 17591280
• Report Number: 2135147-2023-03645
• Device Sequence Number: 2429730
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• 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: 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): 09/21/2023

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: 10/25/2024
• Device Catalogue Number: PRT-23
• Device Lot Number: 8945958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male