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); Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
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 25mm portico valve (19238809) was chosen for a transcatheter aortic valve implantation using a small flexnav delivery system (8421857).The patient had a previously implanted unknown size non-abbott valve in place, and the patient required a valve-in-valve procedure due to pure aortic regurgitation (ar).There was no observed calcium on the existing implanted non-abbott valve.The portico valve was deployed at 3mm.Upon the final release of the portico valve, it migrated down more than 10mm and ended up slightly too deep.Due to the leakage around the valve, they decided to deploy a second 25mm portico valve (19188508) using a small flexnav delivery system (8418404).The second valve was implanted and positioned well.There was no gradient or leak detected post implant.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay.The patient was reported as stable.
Additional Manufacturer Narrative
An event of the valve migration upon release and leakage around 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, and the product met all specifications, including specification for radial force.Based on the information received, the cause of the reported incident could not be conclusively determined.Na.

• 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: 15988975
• Report Number: 2135147-2022-02577
• Device Sequence Number: 5710349
• 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): 02/28/2023

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: 11/15/2024
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 8264718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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: 85 YR
• Patient Sex: Male