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

Model Number PRT-27

Device Problem Central Regurgitation (4068)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/10/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a 27mm portico was implanted.After implantation, an echocardiogram revealed that there was central aortic regurgitation.An angiogram revealed that the valve was slightly constrained in the native annular site.A post balloon valvuloplasty was done and the appearance of the valve improved on the angiogram.The central regurgitation remained.A second post balloon valvuloplasty was conducted, but the regurgitation persisted.The regurgitation was classified as mild to moderate.The patient is reported to be stable.

Manufacturer Narrative

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

Manufacturer Narrative

An event of mild to moderate aortic regurgitation was reported.A more comprehensive assessment, including a histopathological examination of the valve tissue, could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined but the valve oversizing may have contributed to the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.

Event Description

Subsequent to the previously filed report, additional information was received: it was reported that the patient had the following annular dimensions; perimeter =70.9 mm, area = 392.4 mm², minimal diameter = 20.8 mm, maximum diameter= 24.5 mm, mean diameter = 22.7 mm.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.There was no other intervention performed/required and the 27mm portico valve remains implanted.The patient is reported to be discharged at the time of report.

• 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: 15887206
• MDR Text Key: 304538730
• Report Number: 2135147-2022-02274
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRT-27
• Device Catalogue Number: PRT-27
• Device Lot Number: 19345866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female