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| Model Number UNK-NV-SAB |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Intracranial Hemorrhage (1891); Insufficient Information (4580)
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| Event Date 09/07/2020 |
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Event Type
Death
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Manufacturer Narrative
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See for literature article.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Charlotte s.Weyland, ulf neuberger, arne potreck, johannes a.R.Pfaff, simon nagel, silvia schönenberger, martin bendszus, markus a.Möhlenbruch; clinical neuroradiol; 2021; 31:745¿752; reasons for failed mechanical thrombectomy in posterior circulation ischemic stroke patients; https://doi.Org/10.1007/s00062-020-00950.Medtronic received information in a literature article regarding complications with solitaire stents. failed recanalization attempts are subdivided into interventions with futile vascular access and failed thrombus removal.The second group is further classified as failure to pass the target vessel occlusion and as stent-retriever failure, where the thrombus cannot be removed despite all mechanical thrombectomy (mt) maneuvers. the prospective stroke database of heidelberg¿s comprehensive stroke center was searched for all patients with acute ischemic stroke of the posterior circulation and intention to perform mt between march 2009 and april 2019.All cases included were conducted with modern mt techniques at hand starting with the solitaire ab stent in 2009 and continuously modified by adding or exchanging with new material.The choice of catheters and mt maneuver approach (direct thrombus aspiration as first attempt or stent-retriever thrombectomy in solumbra technique) was made by the interventionalist.The thrombectomy technique is changed when a thrombectomy strategy fails (e.G.From aspiration to stent-retriever thrombectomy).As standard approach up to three different stent-retriever devices are used in our facility with up to three attempts per device before terminating unsuccessful mt. all modern stent-retriever models were available. for rescue stenting during mt of persistent basilar artery occlusions a glycoprotein (gp) iib/iiia inhibitor is given for 6h during and after intervention followed by an overlapping loading with double platelet inhibition with aspirin and clopidogrel.The following classification systems for failed recanalization in mt of the anterior circulation, all cases of failed mt were categorized in one of the following groups. category i: target vessel occlusion not reached ia: the intracranial target vessel could not be reached due to difficult aortic anatomy, vessel tortuosity and/or vertebral hypoplasia.Ib: target occlusion was not reached due to atherosclerotic stenosis/occlusion of the vertebral arteries.Category ii: target vessel occlusion reached but not passed ii: the intracranial target vessel was reached but could not be passed for any mt maneuver until the end of the procedure.Category iii: target vessel occlusion reached and passed iiia: target occlusion stayed occluded despite mt maneuvers or vessel lumen reoccluded until the end of the mt.Iiib: after passing the vessel occlusion complications or neurologic deterioration of the patient lead to a termination of the procedure.Overall, 1671 patients underwent mt for acute ischemic stroke in the department between march 2009 and april 2019.Of the patients 218 were treated for ischemic stroke of the posterior circulation.In 30/218 patients (13.8%) the mt failed and 188/218 patients (86.2%) showed a sufficient recanalization result after mt. there was no tendency towards a higher success rate in more recent years while the overall number of mts performed gradually increased.For failed mts average age was 71 ang 63 % male.For successful mts average age was 73 and 58 % male.Mortality was 77 % in the failed mt and 36 percent in the successful mt. stent assisted pta was performed in 30.0% of successful (56 patients) and 30.0% of failed (9 patients) mts, the patients neurologica l deficit (per nihss) and handicap (per mrs) were different with a higher nihss at discharge for patients with failed mt (median (iqr) failed mt 34 (11¿34); successful mt 2/3 8 (3¿34), p-value < 0.001), a higher mortality rate after failed mt (n= 23/30, 77%) and a higher mrs 90 days after stroke onset (median (iqr) failed mt 6 (6¿6), successful mt 4 (2¿6), p-value < 0.001).Also , the pc-aspects in the follow-up imaging (ct or mri, 1¿3 days after mt) was significantly lower after failed mt (median iqr failed mt 5, 3¿7.5, successful mt 7, 5¿8). in both groups, a stent-assisted percutaneous transluminal angioplasty (pta) was performed in 30.0% of the cases during the mt. category i: in 12/30 cases (40.0%) of failed mt, an unsuccessful vascular access was the reason for procedure failure. atherosclerotic stenosis or occlusion of the vertebral arteries was the cause in seven cases (category ia).Anatomic ally difficult access with aortic or vertebral artery elongations was the cause in five cases (category ib). category ii: in 7/30 cases (23.3%) the target vessel occlusion could not be passed with a probable underlying atherosclerotic occlusion stated by the inter ventionalist in five of these cases.Local intra-arterial (i.A.) thrombolysis (rtpa) was performed in 13/218 cases.Four times a persisting basilar artery occlusion was treated with i.A.Rtpa with two successful recanalization results.Six times i.A. rtpa and an additional stent-assisted pta was performed. three times an embolic vessel occlusion (pca and suca) that occurred after recanalization of the basilar artery were targeted. category iii: in 11/30 cases (36.7%), the mt failed after passing the occluded vessel.In three of these cases, the vessel stayed occluded or the vessel lumen reoccluded despite mt maneuvers (category iiia).An emergency stent assisted pta was conducted if possible in these scenarios. stenting of the v4 segment of the vertebral artery and/or the basilar artery was performed in 65/218 cases of mt in the posterior circulation.In 9/65 cases mt failed comprising three device malfunctions (i.E.Stent kinking) and six cases where the stent implantation did not lead to a restoration of the target vessel volume. in five cases, intraprocedural complications (two cases of vessel perforation and three cases of stent kinking or failed stent unfolding) or the patient¿s deteriorating clinical status during the mt let to a termination of the intervention (category iii b).
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Charlotte s.Weyland, ulf neuberger, arne potreck, johannes a.R.Pfaff, simon nagel, silvia schönenberger, martin bendszus, markus a.Möhlenbruch; clinical neuroradiol; 2021; 31:745¿752; reasons for failed mechanical thrombectomy in posterior circulation ischemic stroke patients; https://doi.Org/10.1007/s00062-020-00950.Medtronic received information in a literature article regarding complications with solitaire stents. failed recanalization attempts are subdivided into interventions with futile vascular access and failed thrombus removal.The second group is further classified as failure to pass the target vessel occlusion and as stent-retriever failure, where the thrombus cannot be removed despite all mechanical thrombectomy (mt) maneuvers. the prospective stroke database of heidelberg¿s comprehensive stroke center was searched for all patients with acute ischemic stroke of the posterior circulation and intention to perform mt between march 2009 and april 2019.All cases included were conducted with modern mt techniques at hand starting with the solitaire ab stent in 2009 and continuously modified by adding or exchanging with new material.The choice of catheters and mt maneuver approach (direct thrombus aspiration as first attempt or stent-retriever thrombectomy in solumbra technique) was made by the interventionalist.The thrombectomy technique is changed when a thrombectomy strategy fails (e.G.From aspiration to stent-retriever thrombectomy).As standard approach up to three different stent-retriever devices are used in our facility with up to three attempts per device before terminating unsuccessful mt. all modern stent-retriever models were available. for rescue stenting during mt of persistent basilar artery occlusions a glycoprotein (gp) iib/iiia inhibitor is given for 6h during and after intervention followed by an overlapping loading with double platelet inhibition with aspirin and clopidogrel.The following classification systems for failed recanalization in mt of the anterior circulation, all cases of failed mt were categorized in one of the following groups. category i: target vessel occlusion not reached ia: the intracranial target vessel could not be reached due to difficult aortic anatomy, vessel tortuosity and/or vertebral hypoplasia.Ib: target occlusion was not reached due to atherosclerotic stenosis/occlusion of the vertebral arteries.Category ii: target vessel occlusion reached but not passed ii: the intracranial target vessel was reached but could not be passed for any mt maneuver until the end of the procedure.Category iii: target vessel occlusion reached and passed iiia: target occlusion stayed occluded despite mt maneuvers or vessel lumen reoccluded until the end of the mt.Iiib: after passing the vessel occlusion complications or neurologic deterioration of the patient lead to a termination of the procedure.Overall, 1671 patients underwent mt for acute ischemic stroke in the department between march 2009 and april 2019.Of the patients 218 were treated for ischemic stroke of the posterior circulation.In 30/218 patients (13.8%) the mt failed and 188/218 patients (86.2%) showed a sufficient recanalization result after mt. there was no tendency towards a higher success rate in more recent years while the overall number of mts performed gradually increased.For failed mts average age was 71 ang 63 % male.For successful mts average age was 73 and 58 % male.Mortality was 77 % in the failed mt and 36 percent in the successful mt. stent assisted pta was performed in 30.0% of successful (56 patients) and 30.0% of failed (9 patients) mts, the patients neurologica l deficit (per nihss) and handicap (per mrs) were different with a higher nihss at discharge for patients with failed mt (median (iqr) failed mt 34 (11¿34); successful mt 2/3 8 (3¿34), p-value < 0.001), a higher mortality rate after failed mt (n= 23/30, 77%) and a higher mrs 90 days after stroke onset (median (iqr) failed mt 6 (6¿6), successful mt 4 (2¿6), p-value < 0.001).Also , the pc-aspects in the follow-up imaging (ct or mri, 1¿3 days after mt) was significantly lower after failed mt (median iqr failed mt 5, 3¿7.5, successful mt 7, 5¿8). in both groups, a stent-assisted percutaneous transluminal angioplasty (pta) was performed in 30.0% of the cases during the mt. category i: in 12/30 cases (40.0%) of failed mt, an unsuccessful vascular access was the reason for procedure failure. atherosclerotic stenosis or occlusion of the vertebral arteries was the cause in seven cases (category ia).Anatomic ally difficult access with aortic or vertebral artery elongations was the cause in five cases (category ib). category ii: in 7/30 cases (23.3%) the target vessel occlusion could not be passed with a probable underlying atherosclerotic occlusion stated by the inter ventionalist in five of these cases.Local intra-arterial (i.A.) thrombolysis (rtpa) was performed in 13/218 cases.Four times a persisting basilar artery occlusion was treated with i.A.Rtpa with two successful recanalization results.Six times i.A. rtpa and an additional stent-assisted pta was performed. three times an embolic vessel occlusion (pca and suca) that occurred after recanalization of the basilar artery were targeted. category iii: in 11/30 cases (36.7%), the mt failed after passing the occluded vessel.In three of these cases, the vessel stayed occluded or the vessel lumen reoccluded despite mt maneuvers (category iiia).An emergency stent assisted pta was conducted if possible in these scenarios. stenting of the v4 segment of the vertebral artery and/or the basilar artery was performed in 65/218 cases of mt in the posterior circulation.In 9/65 cases mt failed comprising three device malfunctions (i.E.Stent kinking) and six cases where the stent implantation did not lead to a restoration of the target vessel volume. in five cases, intraprocedural complications (two cases of vessel perforation and three cases of stent kinking or failed stent unfolding) or the patient¿s deteriorating clinical status during the mt let to a termination of the intervention (category iii b).
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Manufacturer Narrative
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Correction: event was reviewed and found to be reported erroneously.***mdr decision correct to not reportable.The solitaire ab device is not marketed in nor similar to any device marketed in the us.No additional supplemental reports are required.*** medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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