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Catalog Number 606SXXX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ischemia (1942)
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Event Date 06/30/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This complaint was found during a recent literature search of this device.The citation is as follows: jin-peng fu, lin liu, hang zhao, gui-feng liu: the efficacy of enterprise stent-assisted coil embolization in the treatment of intracranial wide necked aneurysms by magnetic resonance angiography.Int j clin exp med 2018;11(4):4343-4351.Issn:1940-5901/ijcem0063395.This mdr is being submitted for multiple patients (quantity of 3) with no patient demographics or device specifics.Due to the nature of the complaint, the devices were not returned for analysis nor were sterile lot numbers provided in order to conduct lot history reviews.Concomitant med products due to character limitation: enterprise stent, envoy guiding catheter.Complaint conclusion: as reported in the literature publication entitled ¿the efficacy of enterprise stent-assisted coil embolization in the treatment of intracranial wide necked aneurysms by magnetic resonance angiography¿, three patients who underwent enterprise stent-assisted coil embolization suffered from intraoperative ischemia of arterial aneurysm.Details of post-incident intervention and patient outcome were not reported.The article does not comment on possible factors that may have contributed to the reported event.The objective of the study was to assess the efficacy of enterprise stent-assisted coil embolization using mra on patients with intracranial wide necked aneurysms.A total of 108 patients with intracranial wide-necked aneurysms and admitted in china-japan union hospital of jilin university between february of 2013 and june of 2015 were selected for the study.There were 46 males and 62 females.The age range for the included study subjects was 28 to 73 years old, with a mean age of 48.19 ± 11.48 years old, among which 16 patients suffered from hemorrhage, while 92 patients did not have hemorrhages.Location distributions of arterial aneurysm were as follows: basilar artery aneurysm (n = 7), posterior communicating aneurysms (n = 50), anterior communicating aneurysms (n = 28), and internal carotid artery-ophthalmic artery aneurysm (n = 23).All patients were divided into the enterprise (54 patients performed with enterprise stent-assisted coil embolization) and non-enterprise (54 patients performed with non-enterprise stent-assisted coil embolization) groups.All patients underwent mra and digital angiography examinations and were confirmed with wide-necked aneurysms.The appropriate angle, route, enterprise stent, and coil were selected according to the location of intracranial wide necked aneurysms and the condition of parent artery.After administrating general anesthesia, an envoy guiding catheter (6f or 8f) was indwelled in femoral artery along with perfusion of high-pressure saline water in order to prevent thrombosis and air coming through the catheter.The stent was placed in the parent artery under the optimal route along with microguidewire.The transporting guidewire was removed, followed by pushing the length exchange guide wire.The ¿0.021¿ prowler select plus microcatheter was extracted, and the microcatheter compatible with the spring coil was pushed, during which mesh technology and parallel technology were adopted to perform intravascular embolization of arterial aneurysm.After the intravascular embolization, repeat aortocranial angiography was performed.Three-to-five days prior to the operation, patients were prescribed daily 100 mg enteric-coated aspirin and 75 mg clopidogrel.During the operation, the same daily dosages of the prescribed medications were administered through nasal feeding.After the operation, the same daily dosages were prescribed.Six months post-procedure, the patients were prescribed 100 mg enteric-coated aspirin tablets daily, indeterminately.All follow ups were calculated at the time of discharge, and the clinical outcomes of the two groups were observed using glasgow outcome scale (glasgow gos) (gos score > 3 meant good recovery; gos score = 3 meant poor recovery).All patients were observed and followed up for 6 months, which ended on march 30th, 2016.The modified rankin scale, as well as mra and digital angiography re-examinations of the patients were analyzed every three months.No in-stent restenosis was observed in patients after undergoing digital angiography and mra re-examinations.The study concluded that the efficacy of enterprise stent-assisted coil embolization was superior than non-enterprise stent-assisted coil embolization in treating intracranial wide necked aneurysms, while mra was of high sensitivity and specificity in predicting the efficacy of enterprise stent-assisted embolization in the treatment of intracranial wide necked aneurysms and could be used as an important tool to aid in predicting the efficacy of endovascular interventional therapy for patients with wide-necked intracranial aneurysms.No patient, procedure, or device-specific information (including catalog and lot numbers) was reported in the article.No further information was provided.The prowler select plus microcatheters were not returned for evaluation.Additionally, the sterile lot numbers are not known.No further analysis can be performed for complaints reported without a lot number and for which the associated products will not be returned.Cerebral ischemia is a known potential adverse event that can occur with the use of the enterprise stent and cerebral stenting procedures.Since the prowler catheter may have been placed in the patient at the time of the intraoperative ischemia, these events will be captured to that device as well.Vasospasm and perforation of vessel wall are known procedural complications with microcatheters.Manipulation of devices (including non-cerenovus devices) within the aneurysm or parent vessel can result in aneurysm rupture and vasospasm which can result in ischemia.During interventional procedures, the devices are advanced and withdrawn through accessory arteries to treat the target lesion.The physical manipulation of the arteries may result in embolization of debris from the intimal layers of these arteries.Without films of the procedures, it is not possible to determine which devices were in the patient at the time the events occurred and what device caused the events.Although based on the limited available information no definitive conclusion of root cause can be made, it is possible that procedural and patient factors, including vessel characteristics, may have contributed to the events.There is no evidence to suggest that these events are related to a manufacturing or design issue.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 events were 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.This is one of six product events involved with the literature publication and the associated manufacturer report numbers are 1226348-2018-00643,1226348-2018-00644,1226348-2018-00645,1226348-2018-00646, 1226348-2018-00647,& 1226348-2018-00648.
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Event Description
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As reported in the literature publication entitled ¿the efficacy of enterprise stent-assisted coil embolization in the treatment of intracranial wide necked aneurysms by magnetic resonance angiography¿, three patients who underwent enterprise stent-assisted coil embolization suffered from intraoperative ischemia of arterial aneurysm.Details of post-incident intervention and patient outcome were not reported.The article does not comment on possible factors that may have contributed to the reported event.The objective of the study was to assess the efficacy of enterprise stent-assisted coil embolization using mra on patients with intracranial wide necked aneurysms.A total of 108 patients with intracranial wide-necked aneurysms and admitted in china-japan union hospital of jilin university between february of 2013 and june of 2015 were selected for the study.There were 46 males and 62 females.The age range for the included study subjects was 28 to 73 years old, with a mean age of 48.19 ± 11.48 years old, among which 16 patients suffered from hemorrhage, while 92 patients did not have hemorrhages.Location distributions of arterial aneurysm were as follows: basilar artery aneurysm (n = 7), posterior communicating aneurysms (n = 50), anterior communicating aneurysms (n = 28), and internal carotid artery-ophthalmic artery aneurysm (n = 23).All patients were divided into the enterprise (54 patients performed with enterprise stent-assisted coil embolization) and non-enterprise (54 patients performed with non-enterprise stent-assisted coil embolization) groups.All patients underwent mra and digital angiography examinations and were confirmed with wide-necked aneurysms.The appropriate angle, route, enterprise stent, and coil were selected according to the location of intracranial wide necked aneurysms and the condition of parent artery.After administrating general anesthesia, an envoy guiding catheter (6f or 8f) was indwelled in femoral artery along with perfusion of high-pressure saline water in order to prevent thrombosis and air coming through the catheter.The stent was placed in the parent artery under the optimal route along with microguidewire.The transporting guidewire was removed, followed by pushing the length exchange guide wire.The ¿0.021¿ prowler select plus microcatheter was extracted, and the microcatheter compatible with the spring coil was pushed, during which mesh technology and parallel technology were adopted to perform intravascular embolization of arterial aneurysm.After the intravascular embolization, repeat aortocranial angiography was performed.Three-to-five days prior to the operation, patients were prescribed daily 100 mg enteric-coated aspirin and 75 mg clopidogrel.During the operation, the same daily dosages of the prescribed medications were administered through nasal feeding.After the operation, the same daily dosages were prescribed.Six months post-procedure, the patients were prescribed 100 mg enteric-coated aspirin tablets daily, indeterminately.All follow ups were calculated at the time of discharge, and the clinical outcomes of the two groups were observed using glasgow outcome scale (glasgow gos) (gos score > 3 meant good recovery; gos score = 3 meant poor recovery).All patients were observed and followed up for 6 months, which ended on march 30th, 2016.The modified rankin scale, as well as mra and digital angiography re-examinations of the patients were analyzed every three months.No in-stent restenosis was observed in patients after undergoing digital angiography and mra re-examinations.The study concluded that the efficacy of enterprise stent-assisted coil embolization was superior than non-enterprise stent-assisted coil embolization in treating intracranial wide necked aneurysms, while mra was of high sensitivity and specificity in predicting the efficacy of enterprise stent-assisted embolization in the treatment of intracranial wide necked aneurysms and could be used as an important tool to aid in predicting the efficacy of endovascular interventional therapy for patients with wide-necked intracranial aneurysms.No patient, procedure, or device-specific information (including catalog and lot numbers) was reported in the article.No further information was provided.
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