|
Weiying zhong, hong kuang, ping zhang, xinjian yang, bin luo , aisha maimaitili, yuanli zhao, donglei song, sheng guan, hongqi zhang, yang wang, donghai wang, wandong su, and yunyan wang; frontiers in neurology, 2021, volume 12 article 675917, pipeline embolization device for the treatment of ruptured intracerebral aneurysms: a multicenter retrospective study, doi: 10.3389/fneur.2021.675917.Medtronic received information that pipeline and pipeline flex devices along with markman and navien catheters were involved in events with stroke related complications, procedure-related hemorrhagic complications and mortality.Thirty-eight patients with ruptured intracerebral aneurysms (ia)s who underwent pipeline embolization device (ped) treatment from 2015 to 2020 were retrospectively reviewed.Factors associated with procedure-related stroke (ischemic and hemorrhagic) and clinical and angiography outcomes were analyzed. the patients included 16 men and 22 women with a median age of 51 years (range, 28¿76 years). the aneurysms included 14 (36.8%) saccular ias, 12 (31.6%) blister-like ias, and 12 (31.6%) dissecting ias.Twenty-nine (76.3%) ias were located in the anterior circulation, and 9 (23.7%) were in the posterior circulation.The median size was 4.45mm (range, 1.41¿26.9mm).Perforator involvement was noted in 10 (26.3%) ias, and 2 of the 38 patients (5.3%) had additional aneurysms.The size of the aneurysm and parent vessel.A loading dose of the effectiveness of the antiplatelet regimen was evaluated by a thromboelastogram performed after the procedure for elective cases.Patients usually continually received dual antiplatelet therapy with clopidogrel (75mg daily) for 3¿6 months and aspirin (100mg daily) 6 months after ped deployment.An insufficient response to either drug was treated by dose escalation or substitution with ticagrelor (90mg twice daily).The classical ped and ped flex were used in an equal number of cases (50.0 vs.50.0%).All cases except one (97.4%) involved placement of one ped.The median time from sah onset to ped placement was 10.2 days (range, 2¿45 days).Early ped placement (less than 15 days) was performed in 27 (71.1%) cases.Adjunctive coiling was performed in 22 (57.9%) cases, while ped placement was performed as a stand alone procedure in the remaining cases (42.1%).Complete neck coverage was successfully achieved in all cases. two patients (5.3%) experienced inadequate expansion during ped deployment, requiring balloon angioplasty; one patient had inadequate expansion, which led to acute in-stent thrombosis and death.Immediate complete aneurysm obliteration was achieved in 13 cases (34.2%), and incomplete aneurysm obliteration was noted in 25 cases (65.8%) [including 2 neck remnants (5.3%) and 23 residual aneurysms (60.5%)].Significant contrast stasis in the venous phase was noted in 22 cases (65.6%).Stroke-related complications (hemorrhagic and ischemic) during hospitalization were observed in 12 patients(31.6%).Among them, procedure-related hemorrhagic complications were noted in 4 patients (10.5%), including 2 with saccular aneurysms and 1 with a blister aneurysm with rebleeding during the procedure.All of these patients died within 1 month.Intraparenchymal hemorrhage was discovered in one case during the procedure, which was caused by perforating vessel injury.Conservative treatment was performed, and the patient exhibited a favorable outcome at the last follow-up.Symptomatic procedural related infarction was noted in six cases (15.8%) during hospitalization.The cause in one case of a basilar artery dissecting aneurysm was inadequate ped expansion followed by acute in-stent thrombosis.The aneurysm was not obliterated after ped deployment; therefore, intraoperative thrombolysis was not administered.Although external ventricular drain (evd) placement was performed, this patient died from brainstem and occipital lobe infarction 10 days later.The reason for infarction in one case of a blister-like aneurysm and another case of dissection of the basilar artery may be perforator infarction caused by ped implantation.Procedural-induced or aggravated cerebral vasospasm may have caused infarction in three other cases.Symptomatic non-procedure-related (sah-related) infarctions occurred in two cases (5.3%) during hospitalization.One occurred before ped implantation, and the other occurred 3 days after ped implantation, which was not associated with ped implantation and may have been caused by delayed cerebral vasospasm.Non-stroke-related complications were observed in four (10.5%) patients during hospitalization.One patient (2.6%) experienced a direct carotid cavernous fistula, which was completely obliterated through a transvenous approach.Two patients (5.3%) had symptomatic hydrocephalus and underwent transient evd placement after embolization.Another patient (2.6%) also had symptomatic hydrocephalus but underwent transient evd placement and then ventriculoperitoneal shunt placement after embolization.However, this patient died 1 month later because of intracranial infection.Although two other patients underwent evd placement after intraoperative rupture, no evd-related hemorrhage occurred in this study. the mortality rate was 13.2% (5/38).Three patients died from intraoperative rupture, one patient died from intraprocedural in-stent thrombosis, and the other patient died from intracranial infection after ventriculoperitoneal shunt placement. one case involved a saccular aneurysm in the ophthalmic segment of the internal carotid artery 4 months after the procedure, possibly caused by mild in-stent stenosis, and the symptoms were completely relieved with conservative treatment. the other case involved a basilar artery dissecting aneurysm, and the patient exhibited symptoms of brainstem perforator infarction 15 days after ped placement. the patient also exhibited a favorable outcome at the last follow up. angiographic follow-up data were available for 32 of 33 surviving patients. twenty-seven aneurysms (84.4%) exhibited complete occlusion, and 5 (15.6%) exhibited incomplete obliteration, including 2 (6.3%2) neck remnants and 3 (9.4%) residual aneurysms.No rebleeding occurred after ped placement, and mild in-stent stenosis was only noted in one case with a saccular aneurysm in the ophthalmic segment of the internal carotid artery 4 months later, which did not warrant further intervention.
|
|
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.
|
