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

Model Number PRT-25-IDE

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Aortic Valve Stenosis (1717); Thrombosis/Thrombus (4440)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported during the patients four year follow-up visit, the patient underwent echocardiogram imaging which revealed severe aortic valve stenosis.The patient was started on anticoagulant therapy for treatment of a possible thrombus of the leaflet.No additional information has been provided.(b)(4).

Manufacturer Narrative

Additional information: g3,g6, h2,h6,h10.An event of severe valve stenosis and possible leaflet thrombus was reported.A more comprehensive assessment could not be performed as the device 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Corrected information: e1: initial reporter was corrected.H6: code 1717 aortic valve stenosis was added.

Event Description

Additional information received indicates that the patient's aortic stenosis improved following the start of the anticoagulant therapy that began on the patient's 4 year follow-up.The initial implant of the 25mm portico valve was on 5 october 2017.The patient then stopped the anticoagulant therapy due to intolerance.During the patient's 5 year follow-up after the initial implant of the valve, an echocardiogram revealed worsening aortic stenosis again.The patient resumed taking blood thinners, and the patient was recommended to stay on coumadin for life.The aortic stenosis was ongoing at time of the exit of study.No additional information was provided.Crd_699 - portico ide, us0642 - 6193, r646326301, r646333401.

• Brand Name: PORTICO TAVI VALVE, 25 MM, IDE
• 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; 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: 13252353
• MDR Text Key: 283773713
• Report Number: 3014918977-2021-00125
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2018
• Device Model Number: PRT-25-IDE
• Device Lot Number: 5923630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 61 KG