Model Number H7493941848250 |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problems
Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Perforation (2001)
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Event Date 01/10/2022 |
Event Type
Injury
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Event Description
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It was reported that difficulty removal, shaft break, and perforation occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified mid right coronary artery (rca).A 2.50 x 48mm synergy xd drug-eluting stent was placed in the mid rca.However, the stent balloon would not pull back.The physician tried to remove the balloon but the shaft broke 25cm from the hypotube at the flexible distal portion.A balloon was placed distal to the broken shaft, inflated and dragged the broken device back into the guide.Furthermore, a perforation was noted at the mid rca.The patient became hypotensive and experienced chest pain.The perforation was treated with balloon tamponade.The procedure was prolonged but was able to be completed with a different device.No further patient but they were complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: a synergy xd mr us 2.50 x 48mm stent delivery system was returned for analysis.The device was returned without the stent as it was implanted at the lesion site.The balloon cones were reviewed, and signs of positive pressure applied to them were noted as the balloon folds were noted to be relaxed and crimp stent markings were visible on the balloon body.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found a break at the exchange port region of the shaft polymer extrusion.No other issues noted with device.
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Event Description
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It was reported that difficulty removal, shaft break, and perforation occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified mid right coronary artery (rca).A 2.50 x 48mm synergy xd drug-eluting stent was placed in the mid rca.However, the stent balloon would not pull back.The physician tried to remove the balloon but the shaft broke 25cm from the hypotube at the flexible distal portion.A balloon was placed distal to the broken shaft, inflated and dragged the broken device back into the guide.Furthermore, a perforation was noted at the mid rca.The patient became hypotensive and experienced chest pain.The perforation was treated with balloon tamponade.The procedure was prolonged but was able to be completed with a different device.No further patient but they were complications were reported.
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Search Alerts/Recalls
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