Catalog Number SPD2-050-320 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 04/03/2019 |
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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It was reported that the physician intended to use a protege rx stent to treat a lesion in the common carotid artery.The lesion was not pre-dilated.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped without issue.A spiderfx was used as embolic protection.The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used when advancing the device to the lesion.The spider was deployed at the site and the stent was deployed at the intended target lesion without issue.Upon withdrawal, the devices became stuck and locked up with each other.A 3x8mm balloon was used at the iliac artery to anchor the spider wire and a cut down was performed to change to a ¿mono rail system¿.The devices were retrieved.The patient was transferred to icu and is reported to be doing well.
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Manufacturer Narrative
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Additional information: upon withdrawal the stent's inner sheath stuck to the spider.The inner sheath was removed, the inner wire was cut down and removed.The stent delivery system was withdrawn, and the spider was retrieved using its blue retrieval portion.No surgical intervention was required to remove the devices.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Device evaluation: the protégé rx device was returned with portion of the distal section detached approximately 40mm to the retainer.A portion of the blue outer was damaged, and the inner was exposed proximal to the retainer feet.Visual inspection under magnification reveal the retainer feet was detached.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Image review one image was received from the customer.Per the image, a detachment of the inner distal assembly proximal to the retainer.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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