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

Model Number	PRT-29
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	02/09/2023
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 was selected for implant using a large flexnav delivery system.There was mild to moderate calcification to allow anchoring of the device in the opinion of the user and the patient did not have a horizontal aorta.The sizing of the annular dimensions was aortic annulus perimeter 79,4 mm.During the procedure, the valve was successfully implanted in optimal position 3 mm below the annulus.The flexnav ds was successfully detached and the pigtail guide was removed from the bottom of the non-coronary cusp via wire.Control angiography was performed and evaluated as good.Therefore, the super stiff wire was removed from the left ventricle via pigtail.After 1-2 minutes post deployment, the device migrated up from aortic annulus to ascending aorta.The patient did not have a hypertensive spike or pulmonary hypertensive episode at the time of migration.The physician snared the valve in position and the physician was aware of the ifu warning against snaring the valve.A second 29mm portico valve was implanted in the aortic annulus in correct position.The patient remained stable throughout the procedure and no patient consequences were reported.
Additional Manufacturer Narrative
An event of valve migration from aortic annulus to ascending aorta was reported.Possible contributing factors for valve migration are intra-procedural difficulties, implant depth, annular calcium distribution, deployment or retraction difficulties.Information from field indicated that there was mild to moderate calcification to allow anchoring of the device and that the patient did not have a horizontal aorta.Field also indicated that the valve was successfully implanted in optimal position 3 mm below the annulus.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 specifications.Based on the information received, the cause of 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.".

• 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: 16492322
• Report Number: 2135147-2023-01032
• Device Sequence Number: 6316594
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (Y/N): N
• Initial Reporter Country: BO
• 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): 04/13/2023

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: 11/07/2024
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 8239115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 92 KG