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

Model Number	PRT-27
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/04/2023
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.Literature attachment: iatrogenic ventricular septal defect (vsd) treated with amplatzer pfo occluder.Device following valve in valve (viv) tavrna.
Event or Problem Description
The article, "complex clinical case presentations: fit interventional and structural 4", was reviewed.The research article presented a case study of an 85 year old female with prior coronary stenting and critical aortic stenosis.The patient underwent a transcatheter aortic valve replacement (tavr) using a 27mm portico valve.After implant, there was complications of moderate paravalvular regurgitation requiring balloon valvuloplasty and eventually a valve in valve (viv) tavr using a 26mm sapien-3 edwards valve.Afterwards, routine one month follow up echocardiogram showed the aortic prothesis was well seated without significant stenosis or regurgitation but noted a new restrictive membranous vsd (4mm) with left to right shunt.Ten months later, symptoms prompted admission, where transesophageal echocardiography showed that the membranous vsd had progressed in size from 4mm to 9mm, with peak velocity 3.2 m/s and peak gradient of 40 mmhg.Due to high surgical risk and progressive symptoms, the decision was made to treat the vsd with a 25mm amplatzer pfo occluder device, placed successfully with no residual leak.The patient's symptoms subsequently improved.The article concluded that iatrogenic vsd is a rare, but significant complication following tavr that may be safely managed with percutaneous closure device.Post tavr vsd formation can occur from (1) direct injury to the proximal part of the septum from the guidewire or valve deployment, (2) valve causing excessive pressure on the left ventricular outflow tract (lvot) or (3) calcium burden and location within the lvot and annulus.[the primary author of this article is, syed siddiqullah, md, baylor scott & white the heart hospital plano, dallas, tx,usa].
Additional Manufacturer Narrative
As reported in a research article, an event of moderate paravalvular regurgitation was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device was received for analysis.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 (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: 16900363
• Report Number: 2135147-2023-02008
• Device Sequence Number: 5359469
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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 Model Number: PRT-27
• Device Catalogue Number: PRT-27
• 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: 04/15/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 85 YR
• Patient Sex: Female