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

Model Number	PRT-25
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	10/06/2022
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.Na.
Event or Problem Description
It was reported that on (b)(6) 2022, a 25mm portico valve was selected for an implant.During the procedure the patient's activated clotting time was 350 seconds.Heparin was administrated.During deployment the 25mm portico valve migrated into the ascending aorta.The implant depth at deployment was 3mm and at release was 3mm.There was mild calcification to allow anchoring.The device was snare towards the highest part of the ascending aorta with a non-abbott device.An angiography performed of the aortic root that showed a leak and pericardial effusion.Gradient was measured at 11mmhg with evidence of prosthetic regurgitation.A valve in valve procedure was performed with a new 27mm portico valves that had a final depth of 3mm and a mean gradient of 5mmhg.Post deployment, transthoracic echocardiography showed a trace paravalvular leak without changes to the pericardial effusion and an ejection fraction of 30%, with improvement in contractility.A pericardiocentesis was performed draining 700cc.There was significant decrease in the effusion.About 45 minutes after the end of the procedure with no increase in effusion.The patient was transfer into the coronary unit with mechanical ventilation, vasopressors and inotropic support.Patient status was noted as recovering.The annulus dimensions was noted as perimeter of 69mm.There was no interaction between the delivery system and the deployed valve.It was noted that the patient had a pericardial effusion prior to the implant of the portico valve.The pericardial effusion was due to a previous procedure where the patient had a coronary perforation.The patient's hemodynamic changes were related to the pericardial effusion, low pressure and low wall mobility.
Additional Manufacturer Narrative
An event of the valve migrating after implant was reported.Also reported was pericardial effusion which was due to a previous procedure where the patient had a coronary perforation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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: 15652519
• Report Number: 2135147-2022-01730
• Device Sequence Number: 20324876
• 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): 01/18/2023

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: 06/04/2024
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 8568973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2022
• 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: Required Intervention
• Patient Sex: Unknown