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

Model Number PRT-29

Device Problem Perivalvular Leak (1457)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 10/28/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2022, a 29mm portico valve was selected for an implant.The implant depth was 5mm, and there was a lot of calcium in the left coronary leaflet and presence of calcium in the valve annulus.(1536mm3 by 3mensio).The patient did not have a horizontal aorta.During deployment the device was released too quickly after the final release latch button was pressed.There was also a little more tension on the delivery system than necessary, pushing the device further into the ventricular position.The physician did not snare the device into to position.A new 29mm portico valve was selected and successfully implanted for a valve in valve procedure.Post implant, there was a small leak, noted between the two valves, and mild mitral regurgitation due to poor anterior leaflet mobility, without mitral stenosis on electrocardiogram.The mean gradient 3mmhg and peak gradient 7mmhg.No treatment was provided for the leak and no adverse patient effects.The patient remain hemodynamically stable throughout the procedure.

Event Description

In/a.

Manufacturer Narrative

An event of a small leak between the prothesis was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The implant of the valve inside another portico valve could have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note, per the instructions for use 'the portico¿ valve, is designed to be implanted in the native aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve.".

• Brand Name: PORTICO
• Type of Device: 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: 15846737
• MDR Text Key: 304171394
• Report Number: 2135147-2022-02177
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

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
• Device Operator: Health Professional
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 8238367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male