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

Model Number	PRT-23
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
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 on (b)(6) 2022, a 23mm portico valve was successfully implanted in a patient.It was noted during procedure that the 23mm portico valve migrated after full deployment of the valve.The decision was made to perform a valve-in-valve procedure using another unknown size portico valve to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
An event of valve migration after 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 that the product met all specifications.Based on the information received, the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, "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.".
Event or Problem Description
It was reported that on (b)(6) 2022, a 23mm portico valve (19298839) was successfully implanted in a patient using a small flexnav delivery system.It was noted during procedure that the 23mm portico valve migrated 2mm above the native annulus after full deployment of the valve.The decision was made to perform a valve-in-valve procedure using another 23mm portico valve (19297686) to complete the procedure.There was a clinically significant delay in the procedure.The patient is reported to be stable.Subsequent to the previously filed report, additional information was received that the 23mm portico valve was successfully implanted in a patient using a small flexnav delivery system.The 23mm portico valve was sized using computed tomography measurements.It was noted post-implant via angiogram, that the valve migrated 2 mm above the native annulus.There was no issue retracting the valve into the delivery system and no issues leading the retainer tabs into the retainer receptacle.There was no interaction between the small flexnav delivery system and the 23mm portico valve after full deployment.The deployment lock was depressed when fully deploying the portico valve.A clinically significant delay occurred due to having to snare the 23mm portico valve back to where originally intended and to clear the site for implantation of the second 23mm portico valve.The patient remained hemodynamically stable throughout the procedure and did not experience any clinical signs of symptoms during or after this event.The patient was stable at the time of report.

• 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: 16218647
• Report Number: 2135147-2023-00248
• Device Sequence Number: 7388794
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 02/06/2025
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 8355769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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: Female