| Catalog Number ENCR401600 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Aneurysm (1708); Transient Ischemic Attack (2109)
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| Event Date 11/12/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The initial reporter phone and email address are not available / reported.[conclusion]: the event was reported via the enterprise 2 china study, the 29-year-old male patient (01015/r0110) with no relevant medical history presented with a left posterior cerebral artery fusiform aneurysm (hunt & hess grade 1) at the internal carotid artery on 29-oct-2020 and subsequently underwent a stent-assisted coil embolization using a 4mm x 16mm enterprise 2 (encr401600 / 5876388) vascular reconstruction device (vrd) on 30-oct-2020.The aneurysm had the following dimensions: maximum aneurysm diameter 4mm and neck size 2mm.The parent vessel diameter was 2.5mm.The stent and unspecified coils were successfully placed in the aneurysm.Immediate post-procedure assessment showed raymond-roy score of class i: complete obliteration.There were no reported intraoperative complications or study device deficiencies.Routine neurological examination performed prior to discharge on 30-oct-2020 revealed hunt & hess grade 0 (unruptured aneurysm) and modified rankin scale (mrs) score of 0 (no symptoms at all).Modified information was received on 05 jul 2021.The information indicated that the patient developed an intracranial aneurysm on 02 jul 2021.The aneurysm was considered moderate in severity and required endovascular embolization and hospitalization.The event is ongoing.Per the principal investigator, the event was not related to the study device, study procedure, or dual antiplatelet therapy.On 11 jul 2021, additional information was received indicated that the intracranial aneurysm event on 02 jul 2021 was reoccurrence of the target aneurysm.On 29 july 2021, additional information was received.The information indicated that the principal investigator considered the aneurysm recurrence related to the aneurysm itself.Of the coils implanted during the initial aneurysm treatment, three were cerenovus coils: one 3.5mm x 9cm orbit galaxy complex xtrasoft coil (640cx3509 / 30345372), one 7mm x 21cm orbit galaxy complex fill coil (640cf0721 / 30397397), and one 6mm x 20cm orbit galaxy complex fill coil (640cf0620 / 30401400).There was evidence of coil compaction associated with the aneurysm recanalization observed during the retreatment imaging.The percentage of aneurysm occlusion at the time of the recanalization diagnosis is unknown.The recanalization was not associated with a stroke or thrombotic event.The patient was not symptomatic as a result of the recanalization.The information also indicated that the enterprise 2 stent was patent and covering the aneurysm neck at the time of recanalization.The coils remained within the aneurysm sac.The retreatment procedure was successfully completed on 06 july 2021 with complete aneurysm obliteration.Based on complaint information, the device remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 5876388.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.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, factors which may have a correlation with recanalization following coil embolization include neck size (i.E., wide neck), packing density, and inflow angle.Since the aneurysm reoccurrence necessitated surgical re-treatment to preclude further injury or complications, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ 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.This is one of four products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2021-00042, 3008114965-2021-00350, 3008114965-2021-00351, and 3008114965-2021-00352.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 enterprise 2 china study, the 29-year-old male patient (01015/r0110) with no relevant medical history presented with a left posterior cerebral artery fusiform aneurysm (hunt & hess grade 1) at the internal carotid artery on 29-oct-2020 and subsequently underwent a stent-assisted coil embolization using a 4mm x 16mm enterprise 2 (encr401600 / 5876388) vascular reconstruction device (vrd) on 30-oct-2020.The aneurysm had the following dimensions: maximum aneurysm diameter 4mm and neck size 2mm.The parent vessel diameter was 2.5mm.The stent and unspecified coils were successfully placed in the aneurysm.Immediate post-procedure assessment showed raymond-roy score of class i: complete obliteration.There were no reported intraoperative complications or study device deficiencies.Routine neurological examination performed prior to discharge on 30-oct-2020 revealed hunt & hess grade 0 (unruptured aneurysm) and modified rankin scale (mrs) score of 0 (no symptoms at all).Modified information was received on 05 jul 2021.The information indicated that the patient developed an intracranial aneurysm on 02 jul 2021.The aneurysm was considered moderate in severity and required endovascular embolization and hospitalization.The event is ongoing.Per the principal investigator, the event was not related to the study device, study procedure, or dual antiplatelet therapy.On 11 jul 2021, additional information was received indicated that the intracranial aneurysm event on 02 jul 2021 was reoccurrence of the target aneurysm.On 29 july 2021, additional information was received.The information indicated that the principal investigator considered the aneurysm recurrence related to the aneurysm itself.Of the coils implanted during the initial aneurysm treatment, three were cerenovus coils: one 3.5mm x 9cm orbit galaxy complex xtrasoft coil (640cx3509 / 30345372), one 7mm x 21cm orbit galaxy complex fill coil (640cf0721 / 30397397), and one 6mm x 20cm orbit galaxy complex fill coil (640cf0620 / 30401400).There was evidence of coil compaction associated with the aneurysm recanalization observed during the retreatment imaging.The percentage of aneurysm occlusion at the time of the recanalization diagnosis is unknown.The recanalization was not associated with a stroke or thrombotic event.The patient was not symptomatic as a result of the recanalization.The information also indicated that the enterprise 2 stent was patent and covering the aneurysm neck at the time of recanalization.The coils remained within the aneurysm sac.The retreatment procedure was successfully completed on 06 july 2021 with complete aneurysm obliteration.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 30 september 2021.[additional information]: the event was reported via the enterprise 2 china study, the 29-year-old male patient ((b)(6)) with no relevant medical history presented with a left posterior cerebral artery fusiform aneurysm (hunt & hess grade 1) at the internal carotid artery on (b)(6) 2020 and subsequently underwent a stent-assisted coil embolization using a 4mm x 16mm enterprise 2 (encr401600 / 5876388) vascular reconstruction device (vrd) on (b)(6) 2020.The aneurysm had the following dimensions: maximum aneurysm diameter 4mm and neck size 2mm.The parent vessel diameter was 2.5mm.The stent and unspecified coils were successfully placed in the aneurysm.Immediate post-procedure assessment showed raymond-roy score of class i: complete obliteration.There were no reported intraoperative complications or study device deficiencies.Routine neurological examination performed prior to discharge on (b)(6) 2020 revealed hunt & hess grade 0 (unruptured aneurysm) and modified rankin scale (mrs) score of 0 (no symptoms at all).Modified information was received on 05 jul 2021.The information indicated that the patient developed an intracranial aneurysm on (b)(6) 2021.The aneurysm was considered moderate in severity and required endovascular embolization and hospitalization.The event is ongoing.Per the principal investigator, the event was not related to the study device, study procedure, or dual antiplatelet therapy.On 11 jul 2021, additional information was received indicated that the intracranial aneurysm event on (b)(6) 2021 was reoccurrence of the target aneurysm.On (b)(6) 2021, additional information was received.The information indicated that the principal investigator considered the aneurysm recurrence related to the aneurysm itself.Of the coils implanted during the initial aneurysm treatment, three were cerenovus coils: one 3.5mm x 9cm orbit galaxy complex xtrasoft coil (640cx3509 / (b)(6)), one 7mm x 21cm orbit galaxy complex fill coil (640cf0721 / (b)(6)), and one 6mm x 20cm orbit galaxy complex fill coil (640cf0620 / (b)(6)).There was evidence of coil compaction associated with the aneurysm recanalization observed during the retreatment imaging.The percentage of aneurysm occlusion at the time of the recanalization diagnosis is unknown.The recanalization was not associated with a stroke or thrombotic event.The patient was not symptomatic as a result of the recanalization.The information also indicated that the enterprise 2 stent was patent and covering the aneurysm neck at the time of recanalization.The coils remained within the aneurysm sac.The retreatment procedure was successfully completed on (b)(6) 2021 with complete aneurysm obliteration.On (b)(6) 2021, additional information was received.The information indicated that the aneurysm occlusion was 80% at the time of aneurysm recanalization.The raymond-roy score was class ii.On 18 august 2021, additional information was received.The information indicated that the patient experienced cerebral ischemia on (b)(6) 2020.Butylphthalide soft capsules were administered three times daily from (b)(6) 2020 to (b)(6) 2021.The patient recovered from the event on (b)(6) 2021.Per the pi, the event was mild in severity and possibly related to the study device, study procedure, and dual antiplatelet therapy.The event was not considered serious or disabling.The cerebral ischemia was not associated with in-stent thrombosis or stenosis.Real-time data entered in electronic data capture (edc) was reviewed.The following medications were administered for prevention of thrombosis: aspirin 100mg (start date: (b)(6) 2020, ongoing), clopidogrel bisulfate tablets 75mg (start date: (b)(6) 2020, stop date: (b)(6) 2021), atorvastatin calcium tablets 20mg (start date: (b)(6) 2020, ongoing), natracheparin calcium injection 0.4ml/cc (start date: (b)(6) 2020, end date: (b)(6) 2020), and clopidogrel hydrogen sulphate tablets 75mg (start date: (b)(6) 2021, ongoing).30-day follow-up visit was performed via phone on (b)(6) 2020.Digital subtraction angiography (dsa) performed at the 180-day follow-up visit on (b)(6) 2021 showed raymond-roy classification score of class ii: residual neck (contrast filling in aneurysm neck but none in aneurysm body).There was no evidence of hemorrhage/rupture or in-stent stenosis/thrombosis.Hunt & hess grade was 0 and mrs score was 0.On (b)(6) 2021, additional information was received.The information indicated that the patient experienced blurred vision since (b)(6) 2020.The principal investigator (pi) considered the event may have been related to occipital lobe ischemia, ¿it may improve after blood compensation, besides routine fluid infusion, no other treatment provided.¿ the patient underwent a computed tomography (ct) examination at a local hospital on (b)(6) 2020, which indicated the change of ischemia in splenium of corpus callosum.The pi diagnosed this as cerebral ischemia.The patient was prescribed dl-3-butylphthalide from (b)(6) 2020 to (b)(6) 2021.Only the blurred vision is considered to be related to the occipital lobe ischemia.The other symptoms (limb numbness, vomiting, and headaches) were not considered to be related to the cerebral ischemia.The pi feels that the event may have been caused by cerebrovascular spasm; the event was deemed ¿probably related to the target vessel.¿ at the 180-day follow-up visit, it was confirmed by the patient that the blurred vision had resolved on (b)(6) 2021.There were no residual symptoms.The event lasted for 122 days.The patient did not report any other discomfort.The antiplatelet effectiveness test was not performed.Heparin activated clotting time (act) was not monitored in baseline nor post-procedure.The information indicated that the enterprise stent fully expanded and apposed the vessel wall after its deployment.The enterprise stent demonstrated to be patent.There was no coil protrusion into the parent vessel.On the same day, 30 september 2021, the clinical database was updated.The onset date of the cerebral ischemia event was changed from (b)(6) 2020 to (b)(6) 2020.The event severity was also updated from mild to moderate.Cerebral ischemia is a known potential adverse event associated with the use of the enterprise 2 vrd in the intracranial arteries.With the information provided, it is not possible to determine the root cause of the event.However, there are patient, procedural, and pharmacological factors that may have contributed.There was no information provided to indicate a device malfunction or reason for considering the event to be potentially related to the device.The cerebral ischemia was prolonged (i.E., 122 days) and required medical intervention to prevent permanent impairment.Furthermore, the investigator believes the event was possibly related to the study device.Therefore, the event meets mdr reporting criteria for all implanted cerenovus devices.This is one of four products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2021-00042, 3008114965-2021-00350, 3008114965-2021-00351, and 3008114965-2021-00352.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 submission is to include the additional event information received on 13 august 2021.[additional information]: the event was reported via the enterprise 2 china study, the 29-year-old male patient (01015/r0110) with no relevant medical history presented with a left posterior cerebral artery fusiform aneurysm (hunt & hess grade 1) at the internal carotid artery on (b)(6) 2020 and subsequently underwent a stent-assisted coil embolization using a 4mm x 16mm enterprise 2 (encr401600 / 5876388) vascular reconstruction device (vrd) on (b)(6) 2020.The aneurysm had the following dimensions: maximum aneurysm diameter 4mm and neck size 2mm.The parent vessel diameter was 2.5mm.The stent and unspecified coils were successfully placed in the aneurysm.Immediate post-procedure assessment showed raymond-roy score of class i: complete obliteration.There were no reported intraoperative complications or study device deficiencies.Routine neurological examination performed prior to discharge on (b)(6) 2020 revealed hunt & hess grade 0 (unruptured aneurysm) and modified rankin scale (mrs) score of 0 (no symptoms at all).Modified information was received on 05 jul 2021.The information indicated that the patient developed an intracranial aneurysm on (b)(6) 2021.The aneurysm was considered moderate in severity and required endovascular embolization and hospitalization.The event is ongoing.Per the principal investigator, the event was not related to the study device, study procedure, or dual antiplatelet therapy.On 11 jul 2021, additional information was received indicated that the intracranial aneurysm event on (b)(6) 2021 was reoccurrence of the target aneurysm.On 29 july 2021, additional information was received.The information indicated that the principal investigator considered the aneurysm recurrence related to the aneurysm itself.Of the coils implanted during the initial aneurysm treatment, three were cerenovus coils: one 3.5mm x 9cm orbit galaxy complex xtrasoft coil (640cx3509 / 30345372), one 7mm x 21cm orbit galaxy complex fill coil (640cf0721 / 30397397), and one 6mm x 20cm orbit galaxy complex fill coil (640cf0620 / 30401400).There was evidence of coil compaction associated with the aneurysm recanalization observed during the retreatment imaging.The percentage of aneurysm occlusion at the time of the recanalization diagnosis is unknown.The recanalization was not associated with a stroke or thrombotic event.The patient was not symptomatic as a result of the recanalization.The information also indicated that the enterprise 2 stent was patent and covering the aneurysm neck at the time of recanalization.The coils remained within the aneurysm sac.The retreatment procedure was successfully completed on (b)(6) 2021 with complete aneurysm obliteration.On 13 august 2021, additional information was received.The information indicated that the aneurysm occlusion was 80% at the time of aneurysm recanalization.The raymond-roy score was class ii.Updated sections: g.3, g.6, h.2, and h.10.This is one of four products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00350, 3008114965-2021-00351, and 3008114965-2021-00352.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 submission is to include the additional event information received on 18 august 2021.[additional information]: the event was reported via the enterprise 2 china study, the 29-year-old male patient (01015/r0110) with no relevant medical history presented with a left posterior cerebral artery fusiform aneurysm (hunt & hess grade 1) at the internal carotid artery on (b)(6) 2020 and subsequently underwent a stent-assisted coil embolization using a 4mm x 16mm enterprise 2 (encr401600/5876388) vascular reconstruction device (vrd) on (b)(6) 2020.The aneurysm had the following dimensions: maximum aneurysm diameter 4mm and neck size 2mm.The parent vessel diameter was 2.5mm.The stent and unspecified coils were successfully placed in the aneurysm.Immediate post-procedure assessment showed raymond-roy score of class i: complete obliteration.There were no reported intraoperative complications or study device deficiencies.Routine neurological examination performed prior to discharge on (b)(6) 2020 revealed hunt & hess grade 0 (unruptured aneurysm) and modified rankin scale (mrs) score of 0 (no symptoms at all).Modified information was received on 05 jul 2021.The information indicated that the patient developed an intracranial aneurysm on (b)(6) 2021.The aneurysm was considered moderate in severity and required endovascular embolization and hospitalization.The event is ongoing.Per the principal investigator, the event was not related to the study device, study procedure, or dual antiplatelet therapy.On 11 jul 2021, additional information was received indicated that the intracranial aneurysm event on (b)(6) 2021 was reoccurrence of the target aneurysm.On 29 july 2021, additional information was received.The information indicated that the principal investigator considered the aneurysm recurrence related to the aneurysm itself.Of the coils implanted during the initial aneurysm treatment, three were cerenovus coils: one 3.5mm x 9cm orbit galaxy complex xtrasoft coil (640cx3509/30345372), one 7mm x 21cm orbit galaxy complex fill coil (640cf0721/30397397), and one 6mm x 20cm orbit galaxy complex fill coil (640cf0620/30401400).There was evidence of coil compaction associated with the aneurysm recanalization observed during the retreatment imaging.The percentage of aneurysm occlusion at the time of the recanalization diagnosis is unknown.The recanalization was not associated with a stroke or thrombotic event.The patient was not symptomatic as a result of the recanalization.The information also indicated that the enterprise 2 stent was patent and covering the aneurysm neck at the time of recanalization.The coils remained within the aneurysm sac.The retreatment procedure was successfully completed on (b)(6) 2021 with complete aneurysm obliteration.On 13 august 2021, additional information was received.The information indicated that the aneurysm occlusion was 80% at the time of aneurysm recanalization.The raymond-roy score was class ii.On 18 august 2021, additional information was received.The information indicated that the patient experienced cerebral ischemia on (b)(6) 2020.Butylphthalide soft capsules were administered three times daily from (b)(6) 2020 to (b)(6) 2021.The patient recovered from the event on (b)(6) 2021.Per the pi, the event was mild in severity and possibly related to the study device, study procedure, and dual antiplatelet therapy.The event was not considered serious or disabling.The cerebral ischemia was not associated with in-stent thrombosis or stenosis.Real-time data entered in electronic data capture (edc) was reviewed.The following medications were administered for prevention of thrombosis: aspirin 100mg (start date: (b)(6) 2020, ongoing), clopidogrel bisulfate tablets 75mg (start date: (b)(6) 2020, stop date: (b)(6) 2021), atorvastatin calcium tablets 20mg (start date: (b)(6) 2020, ongoing), natracheparin calcium injection 0.4ml/cc (start date: (b)(6) 2020, end date: (b)(6) 2020), and clopidogrel hydrogen sulphate tablets 75mg (start date: (b)(6) 2021, ongoing).30-day follow-up visit was performed via phone on (b)(6) 2020.Digital subtraction angiography (dsa) performed at the 180-day follow-up visit on (b)(6) 2021 showed raymond-roy classification score of class ii: residual neck (contrast filling in aneurysm neck but none in aneurysm body).There was no evidence of hemorrhage/rupture or in-stent stenosis/thrombosis.Hunt & hess grade was 0 and mrs score was 0.Cerebral ischemia is a known potential adverse event associated with the use of the enterprise 2 vrd in the intracranial arteries.With the information provided, it is not possible to determine the root cause of the event.However, there are patient, procedural, and pharmacological factors that may have contributed.There was no information provided to indicate a device malfunction or reason for considering the event to be potentially related to the device.The cerebral ischemia was prolonged and required medical intervention to prevent permanent impairment.Furthermore, the investigator believes the event was possibly related to the study device.Therefore, the event meets mdr reporting criteria for all implanted cerenovus devices.This is one of four products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2021-00042, 3008114965-2021-00350, 3008114965-2021-00351, and 3008114965-2021-00352.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 submission is to include the additional event information received on 19-oct-2021 and to make a correction to section d.3.[additional information]: on 19-oct-2021, modified information was received from the clinical study database.The modified information is pertaining to the recurrent intracranial aneurysm.The relationship with study device¿ and ¿relationship with study procedure¿ were changed from unrelated to possibly related.This is one of four products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2021-00042, 3008114965-2021-00350, 3008114965-2021-00351, and 3008114965-2021-00352.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.Correction: the incorrect manufacturer name and address were submitted in the initial medwatch.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 12-apr-2022.Additional information: on (b)(6) 2022 modified information was received.Regarding the recurrent intracranial aneurysm event - intravascular interventional treatment was updated from ¿no¿ to ¿yes.¿ the procedure was performed on (b)(6) 2021.Surgical treatment was updated from ¿yes¿ to ¿no¿.This is one of four products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2021-00042, 3008114965-2021-00350, 3008114965-2021-00351, and 3008114965-2021-00352.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 submission is to include the additional / modified event information received on 16-jan-2024.[additional / modified information]: on 16-jan-2024, modified information was received.Per the modified information, the event date for the case should be 02-jul-2021 and the awareness date should be 10-aug-2021.This modified information has been reviewed.There is no new information that alters the previous file type determination, coding, and/or reportability determinations.This is one of four products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2021-00042, 3008114965-2021-00350, 3008114965-2021-00351, and 3008114965-2021-00352.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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Search Alerts/Recalls
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