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

Model Number	PRT-25
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
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 (b)(6) on2022, a 25mm portico valves was selected for an implant using a small flexnav delivery system.The implant depth was 3-5mm and the patient did not have a horizontal aorta.The sizing of the annular dimensions was perimeter 71mm.There was not sufficient calcium for the valve to ancho.During the procedure, the valve was loaded into a small flexnav delivery system.Predilation was done using a 18mm non-abbott balloon.The depth of valve was checked prior to final deployment (80%).Upon checking that depth is optimal, deployment button was depressed and valve was released.The user believes there was tension exerted on the pre-shaped wire.However, at the final release the valve migrated.The patient did not have a hypertensive spike or pulmonary hypertensive episode at the time of migration and the migrated valve did not block a coronary artery or arteries.The valve was snared towards the ascending aorta.The physician is aware of the ifu warning against snaring the valve.Decision was then made to deploy a 2nd 25mm portico valve in a valve in valve procedure.The valve was loaded and deployed successfully with no complication and the patient remains stable throughout the procedure.
Additional Manufacturer Narrative
An event of the valve migrating after implant was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Possible contributing factors for valve migration are intra-procedural difficulties, implant depth, annular calcium distribution, deployment or retraction difficulties.Information from the field indicated that there was not adequate calcium for anchoring and that there was tension from the pre-shaped wire, which could have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 15669879
• Report Number: 2135147-2022-01787
• Device Sequence Number: 6444133
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/17/2023

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: 04/13/2024
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 7971202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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 Sex: Unknown