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

Model Number	PRT-23
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature attachment: tavi-in-tavi in a patient after alcohol septal ablation investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
The article, " tavi-in-tavi in a patient after alcohol septal ablation", was reviewed.This article presented a case study of a 72-year-old woman presented to an outpatient clinic with shortness of breath as a main manifestation, heart failure new york heart association (nyha) functional class iii and nocturnal dyspnea.On the physical examination, the patient had rales heard over both lung bases, blood pressure was 130/70 mm hg, heart rate was 70 beats/min with atrioventricular dual paced rhythm.The patient has an apple shape body habitus and short stature.The patient has a history of hypertrophic obstructive cardiomyopathy (hocm), had a pacemaker implantation 30 years earlier and underwent alcohol septal ablation (asa) for left ventricular outflow tract obstruction 8 years afterwards.Moreover, she had symptomatic severe aortic stenosis 5 years ago.Based on the patient¿s preference and high surgical risk transcatheter aortic valve implantation (tavi) was performed using a lotus 23 mm (boston scientific).The patient was prescribed dual antiplatelet therapy with aspirin and clopidogrel for 6 months followed by aspirin alone.On top of that, paroxysmal atrial fibrillation was detected and treated with amiodarone and rivaroxaban in addition to the treatment of heart failure.Transthoracic echocardiography revealed a left ventricle ejection fraction (lvef) of 35%, lotus aortic valve gradients were 53/29 mmhg and the motion of the right coronary cusp was restricted, there was no aortic regurgitation, moderate mitral regurgitation and high probability of pulmonary hypertension with pulmonary arterial systolic pressure (pasp) above 50 mm hg.Computed tomography (ct) of the heart showed calcification of the lotus aortic valve, but there was no thrombosis or vegetation of the aortic valve.Due to comorbidities and high surgical risk, the heart team recommended a tavi-in-tavi procedure.Estimated euroscore ii and sts score were 8.4% and 8.8% respectively.Tavi-in-tavi under general anesthesia with transfemoral access was performed.First, a 23-mm portico valve was inserted into the degenerated 23-mm lotus valve.Then, post-dilatation with a 20 mm balloon was carried out.The whole procedure was thoroughly prepared.The patient was able to walk on the evening after the procedure.Post-procedure transthoracic echocardiography showed a reduction of transaortic gradients to 16/8 mm hg.After a 3-month follow-up the transaortic gradient stayed low and the patient¿s functional nyha class improved to ii.[the primary author is eva polaková, charles university, motol university hospital, prague, czech republic, e-mail: eva.Polakova@fnmotol.Cz].
Additional Manufacturer Narrative
An event of the device being used off-label inside a lotus valve was reported.Information from the field indicated the lotus valve was calcified and that was why the portico valve was implanted.The reported event was use of the device against the instructions for use, which indicate that "the portico¿ valve, shown below (page 2), 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." there is no indication of a product quality issue with regards to manufacture, design, or labeling.Na.

• 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: 17007653
• Report Number: 2135147-2023-02329
• Device Sequence Number: 17929678
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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-23
• Device Catalogue Number: PRT-23
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/09/2023
• 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: 72 YR
• Patient Sex: Unknown