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

Model Number	PRT-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	07/20/2022
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.
Event or Problem Description
It was reported that on (b)(6) 2022 a 23mm portico valve was successfully implanted using a small flexnav delivery system, in a patient with a history of a left bundle branch block.It was confirmed via electrocardiogram that post-implant the patient was experiencing a complete heart block.The patient had a noted normal sinus rhythm with left bundle branch block prior to implant.There were no recaptures of the 23mm portico valve and no noted complications during the implant procedure.The patient had remained hemodynamically stable throughout the implant procedure.There was no clinically significant delay in procedure reported.The decision was made to implant a permanent pacemaker to treat the complete heart block.The patient was discharged at the time of report.
Additional Manufacturer Narrative
An event of a complete heart block 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 information received, the cause of the reported incident could not be conclusively determined.

• 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: 15226658
• Report Number: 2135147-2022-00774
• Device Sequence Number: 12265273
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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: 04/25/2024
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 7970131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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; Life Threatening
• Patient Sex: Female