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

Model Number	PRT-23
Medical Device Problem Codes	Perivalvular Leak (1457); Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/09/2023
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 23mm portico valve was selected for an implant with the following annular dimensions of the native valve aortic annulus: perimeter: 62.2mm, perimeter derived ø: 19.8mm, area: 292.2 mm², area derived ø: 19.3mm, min ø: 16.6mm, max ø: 22.8mm, average ø: 19.7mm, eccentricity: 0.27, lvot ø: 18.9mm.There was sufficient calcium to allow anchoring of the device in the opinion of the user.During the procedure, the physician went through the right transfemoral route, by severe aortic stenosis.Initially balloon pre-dilation was performed according to minimum diameter of the ring (16 mm).There was a need to recapture it once, before reaching the point implant latch.The device was successfully implanted in a patient with a depth of 4mm.After implantation, moderate leakage was observed by the transesophageal + transthoracic echocardiography and aortography, with perivalvular and transvalvular (central).There was a significant divergence of the pressure curve (diastolic pressure reduced).Post-dilation with a balloon according to the mean diameter of the ring (20 mm), with improvement of the perivalvular component but without improvement of central regurgitation, even after removing the rigid wire (non-abbott device) from inside the left ventricle (lv).Such as patient evolved with hemodynamic instability requiring the use of venous vasopressors.The physician decided to implant a second 23mm portico valve.The second valve was opened and prepared according to the ifu.At this point, when passing the guidewire back into the ventricle for insertion of the second valve, the guidewire touched the implanted valve and released a stuck leaflet.At this time, the patient's blood pressure improved and the central reflux disappeared.The second valve was prepared but not implanted.The patient is stable.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of aortic regurgitation moderate perivalvular leak and incomplete leaflet coaptation was reported.A returned device assessment could not be performed as the device remaines 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.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 17033649
• Report Number: 2135147-2023-02374
• Device Sequence Number: 7012444
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/29/2023

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: 01/08/2026
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 19549453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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: 78 YR
• Patient Sex: Female