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

Model Number	PRT-25
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/21/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2022, a 25mm portico valve was selected for implantation during a transcatheter aortic valve implantation using a flexnav delivery system.The patient had a history of severe aortic stenosis, and prior to the procedure the patients condition was critical.Prior to the procedure the patient had ventricular fibrillation wand went into cardiac arrest.During procedure, a coronary angiography was performed.The patient had low blood pressure at 60mmhg/30mmhg.The patient had continually lowering blood pressure and fell into cardiac arrest.Resuscitation maneuvers were performed, and blood pressure was restored to an average of 50mmhg.A balloon valvuloplasty was performed using a non-abbott balloon to remove aortic stenosis.The 25mm portico valve was released while the patient had low cardiac output, low blood pressure, and low contraction of the heart.A post-dilatation balloon valvuloplasty was performed due to seeing a small waist of the valve.An echocardiogram was performed, and there was no paravalvular leak of the valve.The aortic mean gradient was 4mmhg.The patient went into cardiac arrest and was resuscitated.The patient's blood pressure was restored to normal levels.A few minutes later, the patient went into cardiac arrest without a defined cause and was declared as deceased.It is believed that the device did not contribute towards the low blood pressure or the cardiac arrest.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of patient death during the procedure after the portico valve was implanted was reported.Information from the field indicated that the patient had a medical history of atrioventricular block with a permanent pacemaker and severe aortic stenosis.Information from the field indicated that the patient was critical and had ventricular fibrillation and severe aortic stenosis and went into cardiac arrest before the start of the procedure.The field also, indicated that the patient had low blood pressure and low heart contraction when the valve was released.The field also indicated that there was no paravalvular leak after the valvuloplasty.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The root cause of the reported death may be due to patient comorbidities and ventricular fibrillation which was noted before the procedure and not with the functioning of the abbott device.
Event or Problem Description
N/a.

• Brand Name: PORTICO
• 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: 15977507
• Report Number: 2135147-2022-02543
• Device Sequence Number: 20298223
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/19/2023

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: 07/25/2024
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 8654421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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: Death
• Patient Sex: Unknown