MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PORTICO TAVI VALVE, 25 MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number PRT-25

Device Problems Backflow (1064); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, a 25mm portico valve was selected for implant.Prior to release, the vale was slightly constrained in the non-coronary cusp (ncc) and there was non-uniformed expansion.After full release of the portico valve, the valve migrated up in the ncc and was in supra annular position.Moderate aortic regurgitation (ar) was observed on echo and fluoroscopy.The valve was post-dilated with a non-abbott balloon and a non-abbott valve was successfully implanted as a valve-in-valve.The final implant depth of the portico valve was 4mm in ncc, 5mm in left and right coronary cusps.The patient was reported to be in stable condition.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Manufacturer Narrative

An event of migration and aortic regurgitation was reported.A more comprehensive assessment could not be performed as a valve-in-valve procedure was performed and the device was not accessible 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 TAVI VALVE, 25 MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12844674
• MDR Text Key: 281023189
• Report Number: 3014918977-2021-00091
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: G120263
• 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
• Report Date: 01/06/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 7598888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male