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

Model Number	FNAV-DS-LG
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/12/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2022, a portico valve was chosen for implant using large flexnav delivery system in a patient with aortic stenosis.During the procedure, after the delivery system had been introduced, the patient's blood pressure dropped and was unable to return to normal.It was discovered that there had been an annulus dissection, resulting in the patient passing away during the procedure.It's unknown as to when exactly the annulus dissection occurred during the procedure as the annulus rupture itself was not able to be observed on imaging.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
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Subsequent to the initially filed report, the following information was received that the valve was implanted in the patient.No additional information was provided.
Additional Manufacturer Narrative
An event of a drop in blood pressure and annulus dissection during the procedure resulting in death was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16113641
• Report Number: 2135147-2023-00071
• Device Sequence Number: 20272232
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 03/24/2023

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: 03/23/2024
• Device Model Number: FNAV-DS-LG
• Device Catalogue Number: PRT-27
• Device Lot Number: 7927941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 03/21/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 01/20/2023; 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 27MM PORTICO VALVE, PRT-27, 18917002.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Sex: Male