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

Catalog Number	PRT-27
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
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
Crd_1024 - portico india.In5860 - 22 (r773902801, r774040801).It was reported that on (b)(6) 2023, a 27mm portico valve was selected for an implant in a patient with severe aortic stenosis.The sizing of the annular dimensions of the native valve was perimeter: 74.1mm, area: 411.8 mm sq, diameter 23.4 mm and there was sufficient calcium to allow anchoring of the device in the opinion of the user.The patient did not have a horizontal aorta.During the procedure, calcium distribution was symmetrical.Pre-dilatation of the native aortic valve was done with 22 mm balloon (non-abbott), after which physician attempted valve deployment.Despite 2 resheathing and deploying attempts, the 27 mm portico valve had non uniform expansion and did not open up completely, hence the valve was not fully deployed, it was resheathed and removed.A new 27 mm portico was instead fully deployed and implanted, which opened up well with an implant depth of 4mm.On (b)(6) 2023, it was reported that the valve migrated on echocardiogram.The patient did not have a hypertensive spike or pulmonary hypertensive episode at the time of migration.A valve in valve procedure was performed with another 27mm portico valve.The patient remains hemodynamically stable.
Additional Manufacturer Narrative
An event of non-uniform expansion of the valve was reported.The device was received for examination and no anomalies were noted to the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information form the field indicated that the non-uniform expansion was thought to be due to the heavy calcifications in the patient's annulus.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 health effect - clinical code: code 4582 removed.H6 health effect - impact code: code 2199 removed.

• 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 (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: 17723990
• Report Number: 2135147-2023-03930
• Device Sequence Number: 20620118
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2024
• Device Catalogue Number: PRT-27
• Device Lot Number: 8024107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 55 KG