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

Model Number	PRT-23
Medical Device Problem Codes	Perivalvular Leak (1457); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Heart Block (4444); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(4), patient site id: (b)(6).It was reported that on (b)(6) 2023, a 23mm portico valve was chosen for implant.During the procedure, before the valve was placed, the patient went into asystole and was paced at 180 beats per minute.After the valve was successfully implanted, a temporary pacemaker was placed.On (b)(6) 2023, complete heart block was seen via electrocardiogram.On the same day, a dual chamber pacemaker was successfully implanted.No additional information was provided.
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 heart block and perivalvular leak was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the available information, the cause of the reported event could not be conclusively determined, but the 6 mm depth of implant could have contributed to the heart block.H6 medical device problem code: code 2993 removed.
Event or Problem Description
Clinical information: crd_1024 - portico india, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 23mm portico valve was chosen for implant.During the procedure, before the valve was placed, the patient went into asystole and was paced at 180 beats per minute.After the valve was successfully implanted, a temporary pacemaker was placed.On (b)(6) 2023, complete heart block was seen via electrocardiogram.On the same day, a dual chamber pacemaker was successfully implanted.Subsequent to the initially filed report, the following information was received that the patient experienced complete heart block prior to valve implant.A small flexnav delivery system was used to implant the device.The valve was deployed at 6mm from non-coronary cusp (ncc) and 5mm from left coronary cusp (lcc).The stent protrusion depth was 6mm into the left ventricular outflow tract (lvot).A post balloon aortic valvuloplasty (bav) was performed to address a residual leak in the portico valve.

• 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: 16452937
• Report Number: 2135147-2023-00761
• Device Sequence Number: 5872784
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 8231472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 54 KG