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

Catalog Number PRT-NG-35

Device Problem Perivalvular Leak (1457)

Patient Problems Anemia (1706); Pleural Effusion (2010); Thrombocytopenia (4431); Heart Block (4444)

Event Date 10/25/2022

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_966 - portico ng approval study, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 35mm navitor titan valve was selected for implantation.During the procedure, the valve was re-sheathed two times due to valve placement being too high.After the valve was successfully implanted at 5mm, the patient experienced third degree heart block discovered via found via electrocardiogram (ecg).The patient also experienced mild paravalvular leak, and a 26mm non abbott balloon was used in a post-implant balloon valvuloplasty, a permanent pacemaker was implanted to treat the heart block.After the procedure, an x-ray showed a small pleural effusion.No intervention or treatment was done for the effusion.On (b)(6) 2022, the patient had unusually high troponin levels.On (b)(6) 2022, the patient was diagnosed with thrombocytopenia and anemia.The patient is reported to be discharged.No additional information was provided.

Manufacturer Narrative

An event of heart block, paravalvular leak, thrombocytopenia, anemia, and pleural effusion was reported.A permanent pacemaker was implanted to treat the heart block.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all specifications, including specifications for radial force.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: NAVITOR
• 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 Key: 15831968
• MDR Text Key: 303996793
• Report Number: 2135147-2022-02121
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190023
• 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
• Report Date: 01/20/2023

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 Expiration Date: 06/26/2022
• Device Catalogue Number: PRT-NG-35
• Device Lot Number: 8050948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/20/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White