MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PORTICO TAVI VALVE, 23 MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number PRT-23

Device Problems Perivalvular Leak (1457); Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Migration (4003)

Patient Problems Cardiac Arrest (1762); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/13/2021

Event Type  Injury  

Event Description

It was reported on (b)(6) 2021, a 23mm portico tavi valve was selected for implant.After the valve was implanted a moderate leak and increased gradient was noted and it was decided to do post dilatation.The post dilation was accompanied by angiography and at the end of dilation it seemed that the balloon had completely deflated but when the balloon was pulled out it was noted that it was not completely deflated and the valve "popped" up and migrated into the ascending aorta.The valve was not snared.A valve in valve was performed and a new 25mm portico tavi valve was immediately prepped and during device prep the patient was left in severe aortic insufficiency and went into cardiac arrest.Cpr was performed and the new portico valve was successfully implanted.That patient left the operating room intubated and in a induced coma due to the time experienced in cardiac arrest.Later that night on (b)(6) 2021, the patient died.The physician was sure that the cause of death was not caused by the portico valve but by the overall quality of the balloon.The final depth of the second valve was optimal.Operative notes were requested but cannot be obtained.The patient had a history of aortic stenosis.

Manufacturer Narrative

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

Manufacturer Narrative

An event of paravalvular leak, increased gradient and device migration were 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.

• Brand Name: PORTICO TAVI VALVE, 23 MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13193528
• MDR Text Key: 283418106
• Report Number: 3007113487-2022-00005
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2024
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 7873522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2021
• 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
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 89 YR
• Patient Sex: Female