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

Model Number PRT-23

Device Problems Perivalvular Leak (1457); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Heart Block (4444); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/31/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

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

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 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
• 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: 16452937
• MDR Text Key: 310351864
• Report Number: 2135147-2023-00761
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 54 KG