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

Catalog 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	09/26/2023
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 29mm portico valves was selected for an implant.The patient angulation was 54 degrees and there was sufficient calcium to allow anchoring of the device in the opinion of the user.The sizing of the annular dimensions of the native valve was 27mm diameter, area 559.5mm2, perimeter 84.9mm.During the procedure, after the full deployment of valve, the physician confirmed 3 retained tabs was free and pulled back flexnav, however the device was moved to the ascending aorta due to under expansion.The patient did not have a hypertensive spike or pulmonary hypertensive episode at the time of migration.The device was snared over the coronaries ostium and the physician is aware of the ifu warning against snaring the valve.It was necessary to use a second valve in order to guarantee the successful of the procedure.The patient was stable.
Additional Manufacturer Narrative
An event of valve migration into ascending aorta due to under expansion was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Possible contributing factors for valve migration are intra-procedural difficulties, implant depth, annular calcium distribution, and deployment or retraction difficulties.Information from field indicated that there were no intra-procedural difficulties, there was sufficient calcium to allow anchoring of the device, the angulation was 54 degrees, and there were no difficulties with deployment or retraction noted.The provided videos were reviewed by an abbott technical director of medical affairs, and a cause for the migration was unable to be determined through the review.Based on all available information, a cause for the reported event could not be determined.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: 17943658
• Report Number: 2135147-2023-04541
• Device Sequence Number: 2893538
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• 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): 02/07/2024

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: 06/19/2024
• Device Catalogue Number: PRT-29
• Device Lot Number: 19408275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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: 63 YR
• Patient Sex: Male