Lot Number 0027077682 |
Device Problems
Fracture (1260); Device Damaged by Another Device (2915); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/11/2022 |
Event Type
Injury
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Event Description
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It was reported that stent damage post deployment occurred.The 3.50 x 20mm synergy xd drug eluting stent was implanted in the proximal left anterior descending artery (lad).Three weeks later the patient presented for a staged treatment of the left circumflex (lcx) artery.A non-boston scientific (non-bsc) stent was implanted in the lcx and post-dilated with a non-bsc balloon.When the balloon was being withdrawn, it got caught in the ostial lad.It was noted that the previously implanted synergy was deformed and two struts went into the left main.The physician asked for angiography to check the lad stent which showed it was deformed and withdrawn slightly into the aorta.A synergy megatron was implanted over the ostial lad synergy to crush it and post dilation was performed with a bigger balloon, a 4.50 x 6 nc emerge.The patient condition was stable and the procedure was completed successfully.
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Manufacturer Narrative
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H6 device codes: corrected.
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Event Description
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It was reported that stent damage post deployment occurred.The 3.50 x 20mm synergy xd drug eluting stent was implanted in the proximal left anterior descending artery (lad).Three weeks later the patient presented for a staged treatment of the left circumflex (lcx) artery.A non-boston scientific (non-bsc) stent was implanted in the lcx and post-dilated with a non-bsc balloon.When the balloon was being withdrawn, it got caught in the ostial lad.It was noted that the previously implanted synergy was deformed and two struts went into the left main.The physician asked for angiography to check the lad stent which showed it was deformed and withdrawn slightly into the aorta.A synergy megatron was implanted over the ostial lad synergy to crush it and post dilation was performed with a bigger balloon, a 4.50 x 6 nc emerge.The patient condition was stable and the procedure was completed successfully.
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Search Alerts/Recalls
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