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

Model Number	PRT-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a 25mm portico valves was selected for an implant.The patient has a past medical history of atrial fibrillation.The implant depth of the portico valve was non-coronary cusp (ncc) 5mm and left coronary cusp (lcc) 7mm depth.The patient developed asystole after the portico was delivered.A pacemaker was implanted due to heart block.The patient was reported to be in stable condition.
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 , asystole and pacemaker implantation 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.Information from the field indicated that the valve non-coronary implant depth was 5mm and the left coronary implant depth was 7mm, deeper than the optimal 3 mm depth.Information from the field also indicated that the patient had a history of atrial fibrillation.Based on the information received the cause of the reported incident could not be conclusively determined but could have been caused by a combination of the patient's medical history and implant depth of the valve.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, "prior to release, use appropriate imaging to ensure the struts at the inflow (lvot) portion of the valve are aligned and confirm the depth of the implant is approximately 3 mm (0.12 in.).".

• 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: 15874433
• Report Number: 2135147-2022-02240
• Device Sequence Number: 12134230
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/07/2023

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: 04/21/2024
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 7976538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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 Sex: Female