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

Model Number FNAV-DS-LG

Device Problem Use of Device Problem (1670)

Patient Problem Vascular Dissection (3160)

Event Date 12/12/2022

Event Type  Death  

Event 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.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event 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.

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
• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16113641
• MDR Text Key: 306817065
• Report Number: 2135147-2023-00071
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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
• Treatment: 27MM PORTICO VALVE, PRT-27, 18917002.
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Sex: Male