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

Model Number	PRT-25
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
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 a on (b)(6) 2022 a 25mm portico valve was selected for an implant using a small flexnav delivery system.The patient had a horizontal anatomy with a perimeter 72.5mm.The valve was positioned at 4mm below non-coronary cusp (ncc).During final deployment, the valve migrated and was snared above the sinotubular junction (stj) and away from the coronaries.The physician aware of the ifu warning against snaring the valve.There was no forward or back tension noted on the delivery system during deployment.A valve in valve procedure was performed with a second 25mmprotico valve that was successfully implanted.Patient doing well on post day one echo and discharged over the weekend.
Additional Manufacturer Narrative
An event of the valve migrated during final deployment was reported.A returned device assessment could not be performed as the device remains implanted and 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 defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note that per the instructions for use, "post-implantation precautions: 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.".

• Brand Name: PORTICO
• 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: 16125306
• Report Number: 2135147-2023-00118
• Device Sequence Number: 12388422
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/10/2023

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: 07/25/2025
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 8617222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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 Sex: Unknown