STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEOUS
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Model Number 90495 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vasoconstriction (2126)
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Event Date 09/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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The subject device is unavailable to manufacturer.
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Event Description
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It was reported that the subject device (balloon catheter) was used to treat the clot on the left mca ¿ m2.Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 1, national institute of health stroke scale (nihss) of 22 and mrs (modified rankin score) of 0.The subject device balloon catheter was placed at the high cervical (upper 1/3 of cervical ica) and inflated without any issues.Within 24 hours after the procedure showed tici of 3 and nihss of 2.However, the final imaging showed the severe vasospasm in carotid near the catheter.According to the physician, the vasospasm was related to the subject device.This is due to the distal impaction in tortuose left ica (internal carotid artery).The impaction before the first pass and before the subject device is inflated.This is something very frequent, no symptomatic, not considered adverse event.However, the physician is not considering device issue as the same subject device was used at first pass.The nipodipine (8 ml) was administered to the patient and the vasospasm was recovered at once and the pass was completed with success.The patient¿s current condition is completely functional recovery.Independent, with mrs of 2.
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Manufacturer Narrative
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The device history record review confirms that there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.Therefore, a probable cause of anticipated procedural complication will be assigned to this event.
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Event Description
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It was reported that the subject device (balloon catheter) was used to treat the clot on the left mca ¿ m2.Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 1, national institute of health stroke scale (nihss) of 22 and mrs (modified rankin score) of 0.The subject device balloon catheter was placed at the high cervical (upper 1/3 of cervical ica) and inflated without any issues.Within 24 hours after the procedure showed tici of 3 and nihss of 2.However, the final imaging showed the severe vasospasm in carotid near the catheter.According to the physician, the vasospasm was related to the subject device.This is due to the distal impaction in tortuose left ica (internal carotid artery).The impaction before the first pass and before the subject device is inflated.This is something very frequent, no symptomatic, not considered adverse event.However, the physician is not considering device issue as the same subject device was used at first pass.The nipodipine (8 ml) was administered to the patient and the vasospasm was recovered at once and the pass was completed with success.The patient¿s current condition is completely functional recovery.Independent, with mrs of 2.
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