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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL NAVITOR TAVI VALVE, 29 MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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ST. JUDE MEDICAL NAVITOR TAVI VALVE, 29 MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number NVTR-29
Device Problems Backflow (1064); Perivalvular Leak (1457); Material Split, Cut or Torn (4008)
Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Aortic Valve Insufficiency/ Regurgitation (4450)
Event Date 01/11/2022
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2021, a 29mm navitor tavi valve was successfully implanted.Prior to implant, the patient had a balloon valvuloplasty with a 22mm non-abbott balloon.The decision was made not to post-dilate the valve due to the severe calcification.Post-implant, there was mild a paravalvular leak (pvl) due to eccentric calcification in the annulus, the left ventricular outflow tract (lvot), and the sinotubular junction (stj).Three days after the implant procedure, the patient developed severe aortic regurgitation, and one of the leaflets of the valve appeared to be damaged on echocardiogram.The physician believes that the leaflet of the navitor valve may have been lacerated by sharp calcification supra annularly, since the patient had sharp calcific nodules in the native annulus.On (b)(6) 2022, there was an attempted valve-in-valve implant, but the procedure was abandoned due to insufficient access through the left femoral artery.The patient was also experiencing shortness of breath and pulmonary edema.The primary cause of the pulmonary edema was heart failure.On (b)(6) 2022, the patient was off-loaded with intravenous diuretic therapy.On (b)(6) 2022, the patient had a successful a right femoral artery cutdown procedure, and a 29mm portico valve was successfully implanted inside the 29mm navitor valve.It was reported that the patient no longer has any aortic regurgitation or paravalvular leak.The physician expressed that the patient's anatomy was the issue in this case and not the device.The patient has a past medical history of hypercholesterolemia and diabetes.The patient status was reported as stable.No additional information was provided.
 
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
It was reported that on (b)(6) 2021, a 29mm navitor tavi valve was successfully implanted.Prior to implant, the patient had a balloon valvuloplasty with a 22mm non-abbott balloon.The decision was made not to post-dilate the valve due to the severe calcification.Post-implant, there was mild a paravalvular leak (pvl) due to eccentric calcification in the annulus, the left ventricular outflow tract (lvot), and the sinotubular junction (stj).Three days after the implant procedure, the patient developed severe aortic regurgitation, and one of the leaflets of the valve appeared to be damaged on echocardiogram.The physician believes that the leaflet of the navitor valve may have been lacerated by sharp calcification supra annularly, since the patient had sharp calcific nodules in the native annulus.On (b)(6) 2022, there was an attempted valve-in-valve implant, but the procedure was abandoned due to insufficient access through the left femoral artery.The patient was also experiencing shortness of breath and pulmonary edema.The primary cause of the pulmonary edema was heart failure.On (b)(6) 2022, the patient was off-loaded with intravenous diuretic therapy.On (b)(6) 2022, the patient had a successful a right femoral artery cutdown procedure, and a 29mm portico valve was successfully implanted inside the 29mm navitor valve.It was reported that the patient no longer has any aortic regurgitation or paravalvular leak.The physician expressed that the patient's anatomy was the issue in this case and not the device.The patient has a past medical history of hypercholesterolemia and diabetes.The patient status was reported as stable.No additional information was provided.
 
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, aortic regurgitation, "one of the leaflets of the valve appeared to be damaged", shortness of breath, pulmonary edema, and heart failure 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.
 
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Brand Name
NAVITOR TAVI VALVE, 29 MM
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key13508536
MDR Text Key286265020
Report Number3005334138-2022-00093
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
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 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNVTR-29
Device Lot Number8201386
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
Patient SexMale
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