MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PORTICO NG VALVE, 27MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number PRT-NG-27

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

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dyspnea (1816); Swelling/ Edema (4577)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

(clinical study patient id: (b)(6)).It was reported that on (b)(6) 2021, a 27 mm portico ng valve was successfully implanted.On (b)(6) 2022, the patient presented to ed with heart palpitations (atrial fibrillation).The patient appeared stable and was discharged with instruction to return if symptoms worsen or persist.On (b)(6) 2022, the patient returned to the ed with palpitations, shortness of breath, mild edema in legs, and chest tightness.The patient was placed on medication.On (b)(6) 2022, the patient received tee/cv and was converted to sinus rhythm via cardioversion.No additional information was reported.

Manufacturer Narrative

An event of a patient experiencing an arrhythmia following the implantation of a portico valve was reported.A more comprehensive 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 information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: PORTICO NG VALVE, 27MM
• 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: 14497091
• MDR Text Key: 292801705
• Report Number: 3005334138-2022-00339
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Model Number: PRT-NG-27
• Device Lot Number: 7326375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 70 KG