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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
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EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Tachycardia (2095)
Event Date 01/03/2018
Event Type  Injury  
Event Description
A radiology pt was having an mri of the left knee.Pt stated she has pulmonary atresia.She stated she has a (b)(4) transcatheter heart valve (mri conditional 8).Pt did not bring her implant mri card to have the mri.Mri technologist called the physician, which stated that it was okay for the pt to be put in the mri machine.Once scan started the pt stated had immediate chest pain.Immediately took pt out of scan room, took her vitals in the arthrogram room.Hr (b)(6)-bp (b)(6)- 02:100 at 1745.Charge tech immediately went to operating room for nurse.The nurse checked pt still having some pain.The charge went to get physician.Pt was assessed hr (b)(6)-bp (b)(6)- 02:100.At 1800, pt was brought to the injury clinic for monitoring.Pt stated she was feeling fine.Dr talk to pt and grandmother that if she starts having any kind of pain to go immediately to the er.Pt was in good spirits when she left.Pt also has sternal wires from open heart surgery.Chest pain was of unclear origin.
 
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Brand Name
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
Type of Device
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
irvine CA 92614
MDR Report Key7181718
MDR Text Key97133339
Report NumberMW5074530
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age17 YR
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