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

Model Number	PRT-23
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
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 selected for implant using a small flexnav delivery system.It was noted during procedure that when deploying the 23mm portico valve at a depth of 5mm on the left coronary cusp and 6mm on the non coronary cusp.A 3 cusp and cusp overlap radiographic view was ascertained to assess true depth.The portico valve was deployed and looked sub-annular on full deployment.An unknown guidewire was pulled back to centralize the radiopaque tip of the delivery system.However, it was noted that while the radiopaque tip was being removed as the delivery system interacted with the portico valve and caused it to migrate above the annular plain.The decision was made to implant a second 23mm portico valve using a new small flexnav delivery system to complete the procedure without further complications.The second portico valve was implanted at an optimal depth and the delivery system was able to be removed without issue.The patient remained hemodynamically throughout the procedure and no valve gradient or leak was noted on final aortogram.There were no adverse patient effects reported.The patient was stable and recovering at the time of report.
Additional Manufacturer Narrative
An event of valve migration due to the interaction between delivery system and the portico valve 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 including the valve meeting stent radial force specifications, and the product met all specifications, including specification for radial force.Based on the information received, the cause of reported incident could not be conclusively determined.

• 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: 15663175
• Report Number: 2135147-2022-01769
• Device Sequence Number: 5978888
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• 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): 02/11/2023

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: 07/12/2024
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 8075226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 02/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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: 84 YR
• Patient Sex: Male