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| Model Number ET009521 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Obstruction/Occlusion (2422); No Code Available (3191)
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| Event Date 09/03/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The patient date of birth was not provided/reported.Name, phone and email address of the initial reporter are not available / reported.(b)(4).[conclusion]: the event was reported via the excellent study; the (b)(6)-year-old male patient with a history of gastroesophageal reflux disease (gerd) presented with a witnessed stroke on (b)(6) 2019.The modified treatment in cerebral infarction (mtici) score of 0, nihss score of 26, and a modified rankin score (mrs) of 0.The patient underwent a mechanical thrombectomy using the 5mm x 21mm embotrap ii revascularization device (et009521 / 18j091av) on the same day.Intravenous tissue plasminogen activator (tpa) was not administered at the time of the stroke presentation.The first pass made with the embotrap ii device was with a 0.072¿ inner diameter (id) via a 0.025¿ inner diameter microcatheter and mechanical pump aspiration at right m1 (2 min incubation) resulted in mtici score of 3 with full clot retrieval via the embotrap.No further passes were made.The patient experienced a re-occlusion of the right m1 segment of the middle cerebral artery (mca) on the following day, (b)(6) 2019, which necessitated mechanical thrombectomy and the event resolved with sequelae on the same day.The suspected origin of the embolism was large-artery disease.The 24-hour post-procedure nihss score was 8.The patient was discharged to a rehabilitation center on (b)(6) 2019 with an nihss score of 7.Per the principal investigator (pi), the event was severe and not likely related to the study device or to the study procedure.Modified information received from the clinical database on 31 march 2020 was reviewed.The relationship to the study device value ¿unlikely¿ was changed to ¿possible.¿ per follow-up with the excellent study team confirmed that during the pi¿s re-review of the case, he wanted to re-classify the event.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (18j091av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.In addition, there was no report of malfunction associated with the device.As such, the investigation will be closed.Arterial re-occlusion is a known potential complication associated with acute ischemic stroke cases despite successful endovascular mechanical thrombectomy.According to the referenced literature, predictors of early re-occlusion after initially successful thrombectomies were higher platelets on admission, pre-stroke functional dependency, missed residual thrombotic fragments or stenosis at the primary occlusion site, and stroke of undetermined or other specified pathogenesis.Review of the available information suggests that the severity of the patient¿s baseline stroke may have contributed with no indication of a device deficiency.The progression of the stroke is likely the consequence of the underlying medical pathology.Final mtici score of 3 (complete perfusion) with full clot retrieval was achieved with the use of the embotrap device in one pass, demonstrating that the device performed as intended.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Event Description
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The event was reported via the excellent study; the (b)(6)-year-old male patient with a history of gastroesophageal reflux disease (gerd) presented with a witnessed stroke on (b)(6) 2019.The modified treatment in cerebral infarction (mtici) score of 0, nihss score of 26, and a modified rankin score (mrs) of 0.The patient underwent a mechanical thrombectomy using the 5mm x 21mm embotrap ii revascularization device (et009521 / 18j091av) on the same day.Intravenous tissue plasminogen activator (tpa) was not administered at the time of the stroke presentation.The first pass made with the embotrap ii device was with a 0.072¿ inner diameter (id) via a 0.025¿ id microcatheter and mechanical pump aspiration at right m1 (2 min incubation) resulted in mtici score of 3 with full clot retrieval via the embotrap.No further passes were made.The patient experienced a re-occlusion of the right m1 segment of the middle cerebral artery (mca) on the following day, (b)(6) 2019, which necessitated mechanical thrombectomy and the event resolved with sequelae on the same day.The suspected origin of the embolism was large-artery disease.The 24-hour post-procedure nihss score was 8.The patient was discharged to a rehabilitation center on (b)(6) 2019 with an nihss score of 7.Per the principal investigator (pi), the event was severe and not likely related to the study device or to the study procedure.Modified information received from the clinical database on 31 march 2020 was reviewed.The relationship to the study device value ¿unlikely¿ was changed to ¿possible.¿ per follow-up with the excellent study team confirmed that during the pi¿s re-review of the case, he wanted to re-classify the event.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the updated safety note for the reported event.Modified information received from the clinical database on 31 march 2020 was reviewed.The relationship to the study device value ¿unlikely¿ was changed to ¿possible.¿ per follow-up with the excellent study team confirmed that during the pi¿s re-review of the case, he wanted to re-classify the event.The 90-day follow-up visit was performed by phone on (b)(6) 2019.Mrs score was 1 and there had been no hospitalizations after the index procedure hospitalization.Arterial re-occlusion is a known potential complication associated with acute ischemic stroke cases despite successful endovascular mechanical thrombectomy.According to the referenced literature, predictors of early re-occlusion after initially successful thrombectomies were higher platelets on admission, pre-stroke functional dependency, missed residual thrombotic fragments or stenosis at the primary occlusion site, and stroke of undetermined or other specified pathogenesis.Review of the available information suggests that the severity of the patient¿s baseline stroke may have contributed to the re-occlusion with no indication of a device deficiency.The progression of the stroke is likely the consequence of the underlying medical pathology.Final mtici score of 3 (complete perfusion) with full clot retrieval was achieved with the use of the embotrap device in one pass, demonstrating that the device performed as intended.Reference: predictors of unexpected early reocclusion after successful mechanical thrombectomy in acute ischemic stroke patients originally published: 18-sep-2018.Https://doi.Org/10.1161/strokeaha.118.021685.2018; 49:2643¿2651.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the review of source documentation received on 23 april 2020.Source documentation was forwarded by the excellent study contact on 23 april 2020.The 74-year-old male patient without significant past medical history developed left-sided weakness with aphasia on 02 september 2019.He was thought to have ischemic cerebrovascular accident (cva) but was outside of tpa window.He was flown to fort sanders emergency room (er) for emergency computed tomography (ct) perfusion study which was done upon arrival and showed large area of ischemia involving the majority of the right middle cerebral artery (mca) distribution.The patient subsequently underwent stroke intervention on 02 september 2019.A jet¿ 7 aspiration catheter (penumbra) was advanced over a velocity® delivery microcatheter (penumbra) and a synchro2® standard guidewire (stryker).The 5mm x 21mm embotrap ii revascularization device was advanced through the microcatheter and centered from the mca bifurcation to the distal internal carotid artery.Aspiration was applied via the jet¿ 7 aspiration catheter.Following a waiting period of approximately two minutes, the embotrap device was retrieved and pulled through the reperfusion catheter.Additional aspiration was performed through the reperfusion catheter within the right mca.Following thrombectomy, there was complete reperfusion of the right mca with significant irregularity of the right m1 segment favored to be related to atherosclerosis.Additionally, there was moderate stenosis of the right mca superior division.Some non-occlusive clot may have been noted within the m2 segment of the inferior division.The thrombectomy was considered ¿successful¿ with tici 3 reperfusion; ¿no greater than moderate stenosis however.¿ the patient experienced worsening of left-sided weakness, dysarthria, and right gaze preference on the following day.Non-contrast ct of the brain demonstrated no evidence of significant acute intracranial hemorrhage, mass, mass effect, or midline shift.Atherosclerotic calcifications were present particularly within the right m1 segment of the mca.Lucency within the right basal ganglia was compatible with an evolving acute infarct.Ct angiogram of the neck demonstrated atherosclerosis of the aorta which appeared to be of normal caliber.Intracranially, there was interval re-occlusion of the right mca m1 segment.Additionally, there was a distal m2 occlusion involving the inferior division within the high right sylvian fissure.Scattered intracranial atherosclerosis was present.The patient subsequently underwent a repeat mechanical thrombectomy on (b)(6) 2019.A jet¿ 7 aspiration catheter was advanced over a velocity® delivery microcatheter and a synchro2® standard guidewire.The guidewire was removed and the 5mm x 21mm embotrap ii revascularization device (et009521 / lot#unk) was advanced and centered within the right mca spanning the entirety of the m1 segment.The microcatheter was removed completely.Aspiration was applied via the reperfusion catheter.Following a waiting period, the embotrap was retrieved and pulled through the reperfusion catheter.There was partial recanalization of the right m1 segment.Next, an angiogram was performed through the right internal carotid artery catheter.Another pass was performed with the embotrap in a similar fashion.Repeat angiography was performed.There was complete recanalization of the m1 segment (tici score of 2c).Embolic-appearing clot within the distal m2 segment of the right inferior parietal branch remained.Following two passes of aspiration via a 3max catheter there was persistent clot within this branch.The physician felt this was too distal to safely use a stent retriever.Next, the patient¿s half weight-based loading dose of integrilin was slowly administered into the right internal carotid artery.Repeat angiography demonstrated distal migration and improved filling of the thromboembolism within the m2 branch.The clot was now within a m4 branch.¿somewhat sluggish¿ filling of frontoparietal cortical branches was present which could have been related to either small distal thromboemboli within cortical branches or related to the right m1 segment atherosclerosis with moderate stenosis versus a combination of both.The patient received aspirin and plavix in the neuro-intensive care unit following the procedure.He was discharged to a rehab facility on 06 september 2019 in stable condition.Arterial re-occlusion is a known potential complication associated with acute ischemic stroke cases despite successful endovascular mechanical thrombectomy.According to the referenced literature, predictors of early re-occlusion after initially successful thrombectomies were higher platelets on admission, pre-stroke functional dependency, missed residual thrombotic fragments or stenosis at the primary occlusion site, and stroke of undetermined or other specified pathogenesis.Review of the available information suggests that the severity of the patient¿s baseline stroke may have contributed with no indication of a device deficiency.The progression of the stroke is likely the consequence of the underlying medical pathology.Final mtici score of 3 (complete perfusion) with full clot retrieval was achieved with the use of the embotrap device in one pass, thus demonstrating that the device performed as intended.Reference: predictors of unexpected early reocclusion after successful mechanical thrombectomy in acute ischemic stroke patients.Originally published: 18-sep-2018 https://doi.Org/10.1161/strokeaha.118.021685.2018; 49:2643¿2651.Updated sections: g.4, g.7, h.2, h.10, and concomitant products.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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