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

Model Number	PRT-29
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
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 valve was selected for an implant.The implant depth at deployment was 4mm and there was sufficient calcium to allow anchoring of the device in the opinion of the user.The patient did not have patient have a horizontal aorta.The perimeter: 84,1 mm perimeter derived ø: 26,8 mm area: 540,4 mm².During the final launching of the of the valve, it suddenly migrated to a position that was too aortic.The final implant depth at released was 1mm.There was no tension in the delivery system at the time of final deployment, no hypertensive spike or pulmonary hypertensive episode at the time of migration.It was necessary to use a second 29mm portico valve valve for a valve in valve procedure.Patient status is stable.
Event or Problem Description
It was reported that on (b)(6) 2023 a 29mm portico valve was selected for an implant.The implant depth at deployment was 4mm and there was sufficient calcium to allow anchoring of the device in the opinion of the user.The patient did not have patient have a horizontal aorta.The perimeter: 84,1 mm perimeter derived ø: 26,8 mm area: 540,4 mm².During the final launching of the of the valve, it suddenly migrated to a position that was too aortic.The final implant depth at released was 1mm.There was no tension in the delivery system at the time of final deployment, no hypertensive spike or pulmonary hypertensive episode at the time of migration.It was necessary to use a second 29mm portico valve valve for a valve in valve procedure.Patient status is stable.
Additional Manufacturer Narrative
An event of valve migration 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 defined manufacturing specifications, including specification for radial force.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: PORTICO TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16702694
• Report Number: 2135147-2023-01520
• Device Sequence Number: 5719772
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 06/15/2023

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: 05/02/2025
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 8487780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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: Male