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Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Patient identifier: (b)(6).Procode: krd/hcg.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of four products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00314, 3008114965-2021-00315, and 3008114965-2021-00317.Complaint conclusion: as reported by the (b)(6)study, a (b)(6) year-old female (subject (b)(6)) with a history of controlled hypertension, active smoking, arthritis, asthma, fibromyalgia, osteoporosis, irritable bowel syndrome (ibs), and unruptured left middle cerebral artery (mca) aneurysm underwent balloon-assisted coil embolization of a ruptured right mca bifurcation aneurysm with associated subarachnoid hemorrhage (sah) (hunt & hess grade 2) on (b)(6) 2019.During the procedure, there was a thromboembolic event which necessitated the administration of aggrastat as medical intervention.The patient was asymptomatic; the thromboembolic event was only observed angiographically.Per the information entered in electronic data capture (edc), the event was deemed related to the study procedure with a chance of probable relationship to the device.On (b)(6) 2020, the patient underwent repeat balloon-assisted coil embolization of the target aneurysm due to residual aneurysm.Competitor coils were implanted with complete aneurysm obliteration.The patient was discharged home with self-care on the following day.Immediate pre-procedure angiography on (b)(6) 2019 revealed a ruptured right mca bifurcation aneurysm with the following dimensions: height 2.8mm, dome 7.5mm, maximum aneurysm diameter 7.5mm, neck size 3.2mm, and dome-to-neck ratio 2.3mm.The parent vessel diameter was 2.9mm.Balloon-assisted coil embolization was then performed with the implantation of one 3mm x 6cm galaxy g3 xsft (glx120306/ l15550), two 1mm x 2cm galaxy g3 mini (glm910020/l14092), and one 1mm x 1.5cm galaxy g3 mini (glm910015/l14067) via an excelsior sl-10 (stryker) microcatheter.There was no microcatheter kickback (loss of access to aneurysm) experienced.Heparin was administered during the procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete, and the study coils were successfully implanted at the target site with angiosuite packing density 8.05%.Immediate post-procedure modified raymond-roy classification score was class i: complete obliteration.There were no reported study device deficiencies.The patient was discharged home with self-care on (b)(6) 2019 with mrs score of 0.The 180-day (6-month) follow-up visit was conducted in the clinic on (b)(6) 2020.Mrs score was 1.According to the information documented in edc, there were no protocol-defined reportable adverse events associated with the increase in mrs score.The patient underwent retreatment of the target aneurysm on (b)(6) 2020.Digital subtraction angiography (dsa) performed on (b)(6) 2020 showed complete aneurysm obliteration.Additional information received from the clinical team lead on 29 jun 2021 indicated that the thromboembolic event occurred while placing the fourth coil (the 1.0mm x 1.5cm galaxy g3 mini).Therefore, the thromboembolism was associated with this coil.There was evidence of coil compaction with the four implanted cerenovus coils at the time of the recanalization diagnosis.The modified raymond-roy classification score was class iiib: residual aneurysm with contrast along aneurysm wall.No further information was provided.The device remains implanted; therefore, no product investigation can be performed, and the reported failure could not be evaluated.A manufacturing record evaluation was performed for the finished device l14067 number, and no non-conformances related to the malfunction were identified.Coil compaction with aneurysm recanalization is a known potential complication associated with coil embolization procedures.Coil compaction is the decrease in interspaces between the loops of the coils, which leads to smaller coil mesh.It occurs over time after coil placement.Review of the available information does not allow for an exact determination of root cause; however, according to the referenced publication, patients presenting with sah secondary to ruptured aneurysms are more likely to develop recanalization after coiling procedures.The dynamic nature of ruptured aneurysms and clot lysis appears to promote recanalization.Mural instability and the increased pulsatile pressure of ruptured aneurysms may thus encourage greater coil compaction than that encountered in unruptured counterparts.Lysis of clot may take place as well within thrombus or at rupture sites once related hypercoagulability subsides.Furthermore, the literature publication states that smoking, a large tumor size, a wide-necked aneurysm, an anterior communicating or middle cerebral artery aneurysm, an aneurysm rupture, a volume embolization ratio (ver) < 20%, and an absence of stent assistance are significant risk factors for the postoperative recurrence of an aneurysm.The article also warns that strict follow-up plans should be created for intracranial saccular aneurysm (isa) patients having these high-risk factors.There is no indication of any device defects or manufacturing issues related to the aneurysm recanalization.The file will be re-reviewed if additional information is received at a later date.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.Cerebral thrombosis is a known potential adverse event associated with coil embolization procedures.With the information provided, it is not possible to determine the root cause of the thrombotic event; however, clinical, pharmacological, and procedural factors including this patients pre-procedure presentation with a ruptured aneurysm may have contributed to the event.There have been studies showing evidence for a generalized strong activation of the coagulation and fibrinolytic system in patients with subarachnoid hemorrhage.Based on the available information, there is no indication of any device performance or manufacturing issues related to the reported event.Since the intraoperative thrombotic event required medical intervention to preclude further complications and the relationship of the 1mm x 1.5cm galaxy g3 mini coil (ip-01187337) to the reported event cannot be clearly established (i.E., investigator assessment probable ).The file will be re-reviewed if additional information is received at a later date.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.
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As reported by the (b)(6) study, a (b)(6) year-old female (subject (b)(6)) with a history of controlled hypertension, active smoking, arthritis, asthma, fibromyalgia, osteoporosis, irritable bowel syndrome (ibs), and unruptured left middle cerebral artery (mca) aneurysm underwent balloon-assisted coil embolization of a ruptured right mca bifurcation aneurysm with associated subarachnoid hemorrhage (sah) (hunt & hess grade 2) on (b)(6) 2019.During the procedure, there was a thromboembolic event which necessitated the administration of aggrastat as medical intervention.The patient was asymptomatic; the thromboembolic event was only observed angiographically.Per the information entered in electronic data capture (edc), the event was deemed related to the study procedure with a chance of probable relationship to the device.On (b)(6) 2020, the patient underwent repeat balloon-assisted coil embolization of the target aneurysm due to residual aneurysm.Competitor coils were implanted with complete aneurysm obliteration.The patient was discharged home with self-care on the following day.Immediate pre-procedure angiography on (b)(6) 2019 revealed a ruptured right mca bifurcation aneurysm with the following dimensions: height 2.8mm, dome 7.5mm, maximum aneurysm diameter 7.5mm, neck size 3.2mm, and dome-to-neck ratio 2.3mm.The parent vessel diameter was 2.9mm.Balloon-assisted coil embolization was then performed with the implantation of one 3mm x 6cm galaxy g3 xsft (glx120306/ l15550), two 1mm x 2cm galaxy g3 mini (glm910020/l14092), and one 1mm x 1.5cm galaxy g3 mini (glm910015/l14067) via an excelsior sl-10 (stryker) microcatheter.There was no microcatheter kickback (loss of access to aneurysm) experienced.Heparin was administered during the procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete, and the study coils were successfully implanted at the target site with angiosuite packing density 8.05%.Immediate post-procedure modified raymond-roy classification score was class i: complete obliteration.There were no reported study device deficiencies.The patient was discharged home with self-care on (b)(6) 2019 with mrs score of 0.The 180-day (6-month) follow-up visit was conducted in the clinic on (b)(6) 2020.Mrs score was 1.According to the information documented in edc, there were no protocol-defined reportable adverse events associated with the increase in mrs score.The patient underwent retreatment of the target aneurysm on (b)(6) 2020.Digital subtraction angiography (dsa) performed on (b)(6) 2020 showed complete aneurysm obliteration.The complaint coils remain implanted in the patient and are not available for evaluation.Additional information received from the clinical team lead on 29 jun 2021 indicated that the thromboembolic event occurred while placing the fourth coil (the 1.0mm x 1.5cm galaxy g3 mini).Therefore, the thromboembolism was associated with this coil.There was evidence of coil compaction with the four implanted cerenovus coils at the time of the recanalization diagnosis.The modified raymond-roy classification score was class iiib: residual aneurysm with contrast along aneurysm wall.No further information was provided.
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