MEDTRONIC MEXICO SPRINTER LEGEND RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Catalog Number SPL20025X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 12/22/2018 |
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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An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion exhibiting 70-90% stenosis located in the mid lad.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated using a sprinter legend and nc sprinter balloon.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that the stent failed to cross the lesion and then dislodged into the proximal lad during delivery to/at the lesion.The inflation device remained on neutral pressure during delivery of the dislodged device.A balloon was inserted and inflated to deploy the dislodged stent, the dislodged stent was attached to the previously deployed proximal stent.The target lesion was left untreated.It was indicated that a small dissection occurred, it was reported that the physician believes that the dissection was not caused by a medtronic stent but may have occurred due to pre-dilation balloons.The dissection was left untreated.
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Manufacturer Narrative
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Procedural images: the images capture a lesion site in the lad, with severe calcification evident throughout the proximal lad.Pre-dilation is captured with two balloon devices, possibly the sprinter legend and nc sprinter balloons.A stent is then deployed in the proximal lad.A second stent is then deployed in the proximal lad.The shape of the deployed stent indicates the stent is conforming to the calcification in the vessel.A cloud of contrast next to the deployed stent in the proximal lad suggests this is the site of the reported dissection.The next image captures the dislodged resolute onyx stent within the previously deployed stent in the lad.A balloon device is also visible in the mid lad.The partial inflation of this balloon device is then evident within the previously deployed stent.A balloon device is then inflated at the site of the dislodged stent.No further treatment was evident from the images.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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