STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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Model Number M0035442040 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Neck Pain (2433)
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Event Date 12/26/2016 |
Event Type
Injury
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Manufacturer Narrative
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This is the 2nd of 5 (coils) reports filed associated with this event.Subject device remains implanted.
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Event Description
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The patient underwent successful stent assisted coil embolization of an aneurysm located in the basilar artery apex.Post procedure the patient was assessed having a modified ranking scale (mrs) of 0.It was reported that 21 days post-procedure, the patient experienced right hand numbness.An arterial study treatment was performed of the right upper extremity via a venous doppler ultrasound which revealed a superficial venous thrombosis in the right cephalic vein above the elbow.No deep venous thrombosis was identified.The reported right hand numbness was ongoing.According to the physician, the event was probably related to the procedure, but unrelated to the stent.However it was unknown if the event was related to the implanted coils (subject devices).The patient was assessed having a modified ranking scale (mrs) of 1 at 2 months post the index procedure.No further information is available.
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Manufacturer Narrative
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Expiration date: added.Manufacturing date: added.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However, neurological sequelae (right hand numbness) and thrombosis are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
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Event Description
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The patient underwent successful stent assisted coil embolization of an aneurysm located in the basilar artery apex.Post procedure the patient was assessed having a modified ranking scale (mrs) of 0.It was reported that 21 days post-procedure, the patient experienced right hand numbness.An arterial study treatment was performed of the right upper extremity via a venous doppler ultrasound which revealed a superficial venous thrombosis in the right cephalic vein above the elbow.No deep venous thrombosis was identified.The reported right hand numbness was ongoing.According to the physician, the event was probably related to the procedure, but unrelated to the stent.However it was unknown if the event was related to the implanted coils (subject devices).The patient was assessed having a modified ranking scale (mrs) of 1 at 2 months post the index procedure.No further information is available.
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Manufacturer Narrative
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Executive summary: added: adverse event of right sided-neck pain was added.Sequence of events was edited for clarity.Patient code: added.Additional mfg narrative: added:adverse event of right sided-neck pain was added.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However, right hand numbness, right sided neck pain (neurological sequelae), and thrombosis are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
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Event Description
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The patient underwent successful stent assisted coil embolization of an aneurysm located in the basilar artery apex.Post procedure the patient was assessed having a modified ranking scale (mrs) of 0.It was reported that 20 days post-procedure, the patient experienced right sided neck pain that was resolved the next day without any no residual effects.It was also reported that 21 days post-procedure, the patient experienced right hand numbness that was ongoing.An arterial study treatment of the right upper extremity via a venous doppler ultrasound was performed for the right hand numbness.The arterial study revealed a superficial venous thrombosis in the right cephalic vein above the elbow.No deep venous thrombosis was identified.According to the physician, the right sided neck pain was possibly related to the procedure, but unrelated to the stent.However it was unknown if the right sided-neck pain was related to the implanted coils (subject devices).According to the physician, the right hand numbness was probably related to the procedure, but unrelated to the stent.However it was unknown if it was related to the implanted coils (subject devices).The patient was assessed having a modified ranking scale (mrs) of 1 at 2 months post the index procedure.No further information is available.
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