Model Number 25AGFN-756 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2018, an aortic valve replacement procedure was performed and a 25mm regent valve was implanted.During suturing, a leaflet of the valve dislodged and fell into the left ventricle.Dissection of the left atrium was performed to remove the leaflet.The leaflet was observed to be in the left pulmonary vein and was removed using a forceps.The device was explanted and exchanged for a carbomedics orbis valve (size unknown) and the procedure was completed with no further issues.The patient is reported to be stable.
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Manufacturer Narrative
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The reported event of a dislodged leaflet was confirmed.On leaflet was dislodged from the orifice and returned with the valve.No other damage was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the leaflet dislodgment could not be conclusively determined.Per the site, the leaflet dislodged while testing the valve.Please note per the instructions for use, artmt 100078770 revision b, "do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications.Use a st.Jude medical leaflet tester to gently test valve leaflet mobility.".
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Event Description
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On (b)(6) 2018, an aortic valve replacement procedure was performed and a 25mm regent valve was implanted.During testing of the valve, a leaflet of the valve dislodged and fell into the left ventricle.Dissection of the left atrium was performed to remove the leaflet.The leaflet was observed to be in the left pulmonary vein and was removed using a forceps.The physician confirmed that no leaflet pieces remained in the patient following removal.The device was explanted and exchanged for a 25mm carbomedics orbis valve and the procedure was completed with no further issues.Per the site, the patient remained hemodynamically stable throughout the procedure; however, the procedure time was significantly extended due to the valve replacement.The patient is reported to be stable.
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Search Alerts/Recalls
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