MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. NAVITOR TAVI VALVE, 29 MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number NVTR-29

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

Patient Problem Hemolysis (1886)

Event Date 01/11/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported on (b)(6) 2022, a 29mm navitor tavi valve ((b)(4)) was selected for implant.After deployment, the valve migrated into the ascending aorta.The implant depth was 3mm.The valve was snared and a valve in valve was performed and a 29mm portico, tavi ((b)(4)) was implanted.During deployment of the second valve the valve migrated upon release, during the detachment of the retainer tab from the delivery system and the valve blocked the coronary artery.It was noted that one tab remained attached and the operator rotated the delivery system slightly which led to the migration.The operator reported that they were unable to note if all the tabs were detached due to the location of the first valve ((b)(4)).The implant depth was 5mm and the valve was snared.It was decided to due another valve in valve and a 29mm navitor tavi valve was implanted with a final depth of 4-5mm.Post dilation was performed after the deployment of the third valve.During the implant procedure the patient experienced instable hemodynamic parameters and drop in pressure.Post procedure, the patient was stable and left with a ventricular assist device placed.On (b)(6) 2022, the patient died.The cause of death was due to heart failure.It was noted that the patient's aortic valve calcification was moderate, with no acute aortic angle and the annulus measured 86mm.There no tension noted with any of the delivery systems at time of deployments.Operative and echo images were requested but cannot be obtained.Manufacturer report number: 3007113487-2022-00041.

Manufacturer Narrative

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

Event Description

It was reported on (b)(6) 2022, a 29mm navitor tavi valve ((b)(4)) was selected for implant.After deployment, the valve migrated into the ascending aorta.The implant depth was 3mm.The valve was snared and a valve in valve was performed and a 29mm portico, tavi ((b)(4)) was implanted.During deployment of the second valve the valve migrated upon release, during the detachment of the retainer tab from the delivery system and the valve blocked the coronary artery.It was noted that one tab remained attached and the operator rotated the delivery system slightly which led to the migration.The operator reported that they were unable to note if all the tabs were detached due to the location of the first valve ((b)(4)).The implant depth was 5mm and the valve was snared.It was decided to due another valve in valve and a 29mm navitor tavi valve was implanted with a final depth of 4-5mm.Post dilation was performed after the deployment of the third valve.During the implant procedure the patient experienced instable hemodynamic parameters and drop in pressure.Post procedure, the patient was stable and left with a ventricular assist device placed.On (b)(6) 2022, the patient died.The cause of death was due to heart failure.It was noted that the patient's aortic valve calcification was moderate, with no acute aortic angle and the annulus measured 86mm.There no tension noted with any of the delivery systems at time of deployments.Operative and echo images were requested but cannot be obtained.Manufacturer report number: 3007113487-2022-00041.

Manufacturer Narrative

An event of migration 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.Please note, per the instruction for use, arten600079876 - a, "once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.".

• Brand Name: NAVITOR TAVI VALVE, 29 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: 13479432
• MDR Text Key: 285226435
• Report Number: 3007113487-2022-00040
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NVTR-29
• Device Lot Number: 8229538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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: PRT-29, 18958243
• Patient Outcome(s): Required Intervention; Death