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As reported via the (b)(6) study, a (b)(6) year-old male (subject (b)(6)) with a past medical history of hypertension, tobacco use, alcohol use (sober for 10 years), cannabis use, and class 1 obesity (bmi 33 kg/m2) presented with an unwitnessed stroke on (b)(6) 2020 with nihss score of 11, mrs score of 0, and mtici score of 0 and experienced intraoperative vasospasm which resolved with medication.Per the principal investigator (pi), the event was related to the study procedure but not related to the study device.The patient underwent an endovascular mechanical thrombectomy using a 5x37 embotrap iii (et309537/20g121av ) device on (b)(6) 2020.The suspected origin of embolism was large-artery disease (intracranial atherosclerosis).Intravenous tissue plasminogen activator (tpa) was not administered at the time of stroke presentation.The first pass made with the embotrap and manual aspiration at the right m1 segment of the middle cerebral artery (mca) (3 min incubation) resulted in a mtici score of 2c with clot retrieval via the embotrap and aspirate.Next, proximal lesion aspiration only was performed.Final/end of procedure mtici score was 2c.The embotrap pass was made with a 9f merci balloon guide catheter via an 0.021" headway microcatheter.The patient experienced vasospasm during the procedure which was reversed with medication.24-hour post-procedure nihss score was 4.The patient was discharged to a rehabilitation center on (b)(6) 2020 with mrs score of 2.Modified information received on 23-nov-2020 indicated that the adverse event was classified as not serious and the severity value was updated to severe.Additional information received from the clinical site on 04-jan-2021 indicated that the vasospasm occurred after the first pass made with the embotrap.The vasospasm occurred at the distal cervical internal carotid artery.No other codman/cerenovus devices were used at the time of this event.As per the source document of the operative report provided, details reads as follows: headway 21 microcatheter (mc) was used with a traxcess 14 microwire and the occlusion was easily crossed with the wire and the mc.Mc was advanced into the posterior division m2 where angiography was then performed.This showed good catheter position beyond the occlusion and somewhat stagnant flow but collateral into the branch was present.5x37 embotrap iii was then deployed across the occlusion.Follow up angiography showed good flow through the occlusion into both m2 divisions.Short occlusion segment was present.After proximally 2 minutes aspiration on the balloon guide catheter was performed as the retriever was removed.¿considerable resistance was encountered as the retriever was removed.¿ a small amount of clot was seen on the retriever but none in the aspirate.¿follow-up angiography initially was limited as severe vasospasm was present in the distal cervical internal carotid artery.5mg intra-arterial verapamil was given and 200 mcg nitroglycerin was given as there was nearly no antegrade flow into the brain and results of the retrieval pass could not be determined.¿after a few minutes the internal carotid artery started to open up and the guide catheter had been pulled down.Follow up angiography showed opening of the m1 but underlying stenosis was suspected.Filling into both anterior and posterior division middle cerebral territory was present but slow and there was still retrograde filling from the anterior cerebral artery and part of the territory.Patient was then heparinized then intraarterial aggrastat was given.Concern that the stenosis would reocclude was present.Next day 3-max was used with a cerenovus large bore 071 aspiration catheter which was advanced up to the site of stenosis and residual clot and aspiration was performed on the large bore catheter.It was pulled back into the proximal m1 and repeat angiography showed persistent filling defect distal and severe stenosis.The 3 max catheter was then advanced through the large bore catheter into the stenosis and aspiration was performed with a pump on the 3 max catheter which was passed through the stenosis.3 max was then removed and follow up angiography through the large bore catheter showed improved filling but still some residual hazy probable thrombus.Large bore catheter was removed.¿cervical carotid artery angiography was performed through the guide catheter which show that the vasospasm had resolved¿.
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Product complaint #: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported via the excellent study, a 57-year-old male (subject (b)(6)) with a past medical history of hypertension, tobacco use, alcohol use (sober for 10 years), cannabis use, and class 1 obesity (bmi 33 kg/m2) presented with an unwitnessed stroke on (b)(6) 2020 with nihss score of 11, mrs score of 0, and mtici score of 0 and experienced intraoperative vasospasm which resolved with medication.Per the principal investigator (pi), the event was related to the study procedure but not related to the study device.The patient underwent an endovascular mechanical thrombectomy using a 5x37 embotrap iii (et309537/20g121av) device on (b)(6) 2020.The suspected origin of embolism was large-artery disease (intracranial atherosclerosis).Intravenous tissue plasminogen activator (tpa) was not administered at the time of stroke presentation.The first pass made with the embotrap and manual aspiration at the right m1 segment of the middle cerebral artery (mca) (3 min incubation) resulted in a mtici score of 2c with clot retrieval via the embotrap and aspirate.Next, proximal lesion aspiration only was performed.Final/end of procedure mtici score was 2c.The embotrap pass was made with a 9f merci balloon guide catheter via an 0.021" headway microcatheter.The patient experienced vasospasm during the procedure which was reversed with medication.24-hour post-procedure nihss score was 4.The patient was discharged to a rehabilitation center on (b)(6) 2020 with mrs score of 2.Modified information received on 23-nov-2020 updated ¿ is the adverse event serious? " value to no and ¿severity value" has been changed to severe.Edc has been reviewed and changes have been confirmed.Additional information received from the clinical site on (b)(6) 2021 indicated that the vasospasm occurred after the first pass made with the embotrap.The vasospasm occurred at the distal cervical internal carotid artery.No other codman/cerenovus devices were used at the time of this event.As per the source document of the operative report provided, details reads as follows: headway 21 microcatheter (mc) was used with a traxcess 14 microwire and the occlusion was easily crossed with the wire and the mc.Mc was advanced into the posterior division m2 where angiography was then performed.This showed good catheter position beyond the occlusion and somewhat stagnant flow but collateral into the branch was present.5x37 embotrap iii was then deployed across the occlusion.Follow up angiography showed good flow through the occlusion into both m2 divisions.Short occlusion segment was present.After proximally 2 minutes aspiration on the balloon guide catheter was performed as the retriever was removed.¿considerable resistance was encountered as the retriever was removed.¿ a small amount of clot was seen on the retriever but none in the aspirate.¿follow-up angiography initially was limited as severe vasospasm was present in the distal cervical internal carotid artery.5mg intra-arterial verapamil was given and 200 mcg nitroglycerin was given as there was nearly no antegrade flow into the brain and results of the retrieval pass could not be determined.¿after a few minutes the internal carotid artery started to open up and the guide catheter had been pulled down.Follow up angiography showed opening of the m1 but underlying stenosis was suspected.Filling into both anterior and posterior division middle cerebral territory was present but slow and there was still retrograde filling from the anterior cerebral artery and part of the territory.The patient was then heparinized then intraarterial aggrastat was given.Concern that the stenosis would reocclude was present.Next day 3-max was used with a cerenovus large bore 071 aspiration catheter which was advanced up to the site of stenosis and residual clot and aspiration was performed on the large bore catheter.It was pulled back into the proximal m1 and repeat angiography showed persistent filling defect distal and severe stenosis.The 3 max catheter was then advanced through the large bore catheter into the stenosis and aspiration was performed with a pump on the 3 max catheter which was passed through the stenosis.3 max was then removed and follow up angiography through the large bore catheter showed improved filling but still some residual hazy probable thrombus.Large bore catheter was removed.¿cervical carotid artery angiography was performed through the guide catheter which shows that the vasospasm had resolved¿.The device has not been returned for analysis and therefore no further investigation can be performed at this time.A review of the manufacturing documentation associated with lot number 20g121av presented no issues during the manufacturing or inspection process that can be related to the reported event.Vessel spasm and withdrawal difficulty are known potential complications associated with the embotrap revascularization device.Vessel spasm is a brief temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow distal to the spasm and may occur when positioning/advancing the devices through the vessel/arteries.This is a well-known potential complication with any invasive procedure during which devices are introduced into vessels.A review of the available information suggests that vessel characteristics, patient and procedural factors may have contributed to the reported vasospasm rather than a manufacturing issue or defect of the device.Regarding withdrawal difficulty, the ifu warns the user to not withdraw the device against significant resistance.The cause of the resistance should be assessed using fluoroscopy and the microcatheter should be advanced over the device to resheath or partially resheath to aid in withdrawal.The root cause of the event cannot be conclusively determined based on the information available for review; however, it is likely that clinical and procedural factors, including vessel characteristics and excessive device manipulation, may have contributed.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
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