Catalog Number RONYX27530JX |
Device Problems
Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Thrombus (2101)
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Event Date 11/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During a procedure a resolute onyx coronary drug eluting stent was used to treat a moderately tortuous and calcified lesion exhibiting 75% stenosis located in the left main (lm) coronary artery, and proximal-mid lad.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered while advancing the device.Excessive force was not used during delivery.After pre-dilation was performed a 2.25x38mm non-medtronic stent was implanted in the mid-distal lad.Dilation was carried out several times for proximal-mid lad using a 2.0x15mm non-medtronic balloon from 10-16atm.The resolute onyx 2.75x30mm stent was next implanted in the proximal-mid lad at 12atm.A 4.0x15mm non-medtronic balloon was then implanted in the left main trunk (lmt) ostium of lad to overlap the resolute onyx.A 4.0mm stent balloon was inflated at 6 atm in the overlapping part.Thereafter the stent balloon reached the lmt and was inflated to 20 atm.Thereafter, kissing balloon technique (kbt) was performed at lmt.An angiography was performed and showed that there were no issues and that all stents were sufficiently adhered to the vessel wall.The procedure was completed.It was reported that 7 days post procedure the patient presented with chest pain.A coronary angiography (cag) was performed showing an in stent thrombosis in the overlapping part of the stent.The thrombosis was treated by aspiration.Ivus was performed and showed that there was insufficient post dilation and that the overlapping portion of the stent was not sufficiently expanded.Post dilation was performed several times from 16atm to 23atm with a 2.5x15mm nc balloon, timi 3 flow developed, and then, the dilation was performed in lmt with a 4.0x15mm nc balloon.Post dilation was also performed in the proximal-mid lad using 3.0x15mm nc balloon at 23atm.Ivus was performed and showed that the stent expanded well.An angiography was performed with no issues noted and the procedure was completed.The patient is reported to be alive.No further patient injury has been reported.
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Manufacturer Narrative
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Correction: a 4.0 x 15mm non-medtronic stent was then implanted in the left main trunk (lmt) ostium of lad to overlap the resolute onyx.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The device was being used to treat a lesion exhibiting 90% stenosis.The patient was treated with dapt post implantation.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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