MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PORTICO NG VALVE, 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number PRT-NG-29

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Transient Ischemic Attack (2109); Syncope/Fainting (4411); Heart Block (4444)

Event Date 11/09/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, a 29mm portico ng valve was implanted.Approximately 24hours post-implant, new onset increased troponin was observed from an unknown cause.However, no treatment was required and the patient was discharged home in stable condition.On (b)(6) 2021, the patient presented to the hospital with syncope and bradycardia.Ecg was performed, which showed 1st degree atrioventricular block and left bundle branch block.Telemetry showed multiple pauses, so isoprenaline infusion was initiated, as well as transcutaneous pacing for breakthrough pauses.The patient received a pacing wire, but then was implanted with a permanent pacemaker.No patient consequences were reported.(b)(6).

Manufacturer Narrative

An event of "new onset increased troponin", syncope, bradycardia, atrioventricular block, and left bundle branch block was reported.A more comprehensive assessment could not be performed as the device remains implanted 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 NG VALVE, 29MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13003237
• MDR Text Key: 282228899
• Report Number: 3014918977-2021-00102
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PRT-NG-29
• Device Lot Number: 8008303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 102 KG