• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT MEDICAL NAVITOR TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Catalog Number PRT-NG-29
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Renal Failure (2041); Heart Block (4444)
Event Date 02/01/2023
Event Type  Injury  
Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Event Description
Crd_1003 - vantage ide study, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 29mm portico ng valve was implanted.The patient's baseline rhythm is sinus rhythm with first degree atrioventricular block.During the procedure, during valve implantation, the patient experienced 3rd degree heart block and new onset atrial fibrillation.On (b)(6) 2023, a permanent pacemaker was implanted to treat the heart block.On 03 february 2023, the patient was diagnosed with acute kidney failure, however no treatment was required.On (b)(6) 2023, the patient was discharged.
 
Manufacturer Narrative
An event of third degree heart block, acute kidney failure and new onset atrial fibrillation was reported.A returned device assessment could not be performed as the device remains implanted and 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 available information, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
 
Event Description
Crd_1003 - vantage ide study, patient site id: eu3571 - (b)(6).It was reported that on (b)(6) 2023, a 29mm portico ng was implanted.The patient's baseline rhythm is sinus rhythm with first degree atrioventricular block.During the procedure, during valve implantation, the patient experienced 3rd degree heart block and new onset atrial fibrillation.On (b)(6) 2023, a permanent pacemaker was implanted to treat the heart block.On (b)(6) 2023, the patient was diagnosed with acute kidney failure, however no treatment was required.On (b)(6) 2023, the patient was discharged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NAVITOR TRANSCATHETER AORTIC VALVE
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL #3014918977
edificio #44 calle 0, ave. 2
el coyol alajuela 1897- 4050
CS   1897-4050
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key16438595
MDR Text Key310227051
Report Number2135147-2023-00667
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P190023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/09/2023
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 Catalogue NumberPRT-NG-29
Device Lot Number19353986
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/01/2023
Initial Date FDA Received02/24/2023
Supplement Dates Manufacturer Received05/03/2023
Supplement Dates FDA Received05/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2022
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 Age75 YR
Patient SexMale
Patient Weight81 KG
-
-