Model Number 27MECJ-502 |
Device Problems
Fracture (1260); Material Split, Cut or Torn (4008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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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) 2019, a 27mm masters mechanical valve was selected for implant.During the procedure, one of the leaflets broke as the physician was rotating the valve.The patient is recovering.Attempt to obtain additional information were unsuccessful.No further information is available.
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Manufacturer Narrative
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The reported event of "one of the leaflets broke" was confirmed.Both leaflets were 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.Please note, per the instructions for use artmt100045600 version a, "using the valve holder/rotator and an sjm valve holder handle, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/ rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.".
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Event Description
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On (b)(6) 2019, a 27mm masters mechanical valve was selected for implant.During the procedure, one of the leaflets broke as the physician was rotating the valve.All pieces were confirmed to be removed.A new 25mm masters valve was successfully implanted.The user does not allege a clinically significant prolonged procedure time and the patient was hemodynamically stable throughout the procedure.The patient is recovering.
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Manufacturer Narrative
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Corrected information section: h6.
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Event Description
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(b)(6) 2019 jl: additional information received on (b)(6) 2019 indicated that pieces of the valve were confirmed to be removed.A 25mm masters valve was successfully implanted.The user does not allege a clinically significant prolonged procedure time and the patient was hemodynamically stable throughout the procedure.On (b)(6) 2019, a 27mm masters mechanical valve was selected for implant.During the procedure, one of the leaflets broke as the physician was rotating the valve.The patient is recovering.Attempt to obtain additional information were unsuccessful.No further information is available.
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Search Alerts/Recalls
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