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| Catalog Number ET307537 |
| Device Problems
Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Vascular Dissection (3160)
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| Event Date 11/03/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, race, and ethnicity, were not provided.The initial reporter phone and email address are not available / reported.[conclusion]: the event was reported via the (b)(6) study; the (b)(6) year-old male patient with a history of atrial fibrillation, diabetes, hyperlipidaemia, hypertension, and aortic heart-valve therapy (tavi) presented with a witnessed stroke on (b)(6) 2020 with a modified treatment in cerebral infarction (mtici) score of 1, nih stroke scale score of 17, and modified rankin score (mrs) of 2 experienced severe bleeding on (b)(6) 2020.Per the principal investigator, the event was considered serious and causally related to the study device and procedure.The bleeding was caused by a reopened / ruptured vessel that required endovascular intervention of coiling.The patient was considered recovered and the event resolved on (b)(6) 2020.The patient underwent an endovascular mechanical thrombectomy procedure using a 5mm x 37mm embotrap iii revascularization device (et307537 / 20g136av).Intravenous tissue plasminogen (tpa) was not administered at the time of stroke presentation.The suspected origin of the embolism was cardioembolic.The first pass was made with the embotrap iii and manual aspiration at the right m1 segment of the middle cerebral artery (mca) with 5-minute incubation resulted in an mtici score of 2a with no clot retrieval.The second pass was made with the embotrap iii device and manual aspiration with 5-minute incubation at the right m1 segment of the mca resulted in an mtici score of 2a with no clot retrieval.Per the case report form (crf), no further passes were made.The two passes made with the embotrap iii device was made with an 8f flowgate2¿ balloon guide catheter (stryker), 0.061¿ axs catalyst¿ 6 da catheter (stryker) via a 0.021¿ trevo trak 21 microcatheter (stryker).There were no reported study device deficiencies.The final / end of the procedure mtici score was 2a.The patient¿s nihss score was 4 and mrs score was 3 on (b)(6) 2020.The patient was discharged to another hospital on (b)(6) 2020.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (20g136av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.In addition, there was no report of malfunction associated with the device.As such, the investigation will be closed.Vessel perforation and cerebral hemorrhage are well-known extensively documented potential complications associated with endovascular mechanical thrombectomy and is listed in the embotrap instructions for use (ifu) as such.The exact root cause of the event cannot be determined based on the limited information available for review; however, clinical and procedural factors including vessel characteristics, tortuosity, device selection, and mechanical manipulation of devices within the artery are all factors that may contribute to dissection / perforation.Since the principal investigator assessed these events as serious and casually related to the study device and procedure and the events required surgical intervention to preclude further injury, the event meets mdr reporting criteria.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.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 (b)(6) study; the (b)(6) year-old male patient with a history of atrial fibrillation, diabetes, hyperlipidaemia, hypertension, and aortic heart-valve therapy (tavi) presented with a witnessed stroke on (b)(6) 2020 with a modified treatment in cerebral infarction (mtici) score of 1, nih stroke scale score of 17, and modified rankin score (mrs) of 2 experienced severe bleeding on (b)(6) 2020.Per the principal investigator, the event was considered serious and causally related to the study device and procedure.The bleeding was caused by a reopened / ruptured vessel that required endovascular intervention of coiling.The patient was considered recovered and the event resolved on (b)(6) 2020.The patient underwent an endovascular mechanical thrombectomy procedure using a 5mm x 37mm embotrap iii revascularization device (et307537 / 20g136av).Intravenous tissue plasminogen (tpa) was not administered at the time of stroke presentation.The suspected origin of the embolism was cardioembolic.The first pass was made with the embotrap iii and manual aspiration at the right m1 segment of the middle cerebral artery (mca) with 5-minute incubation resulted in an mtici score of 2a with no clot retrieval.The second pass was made with the embotrap iii device and manual aspiration with 5-minute incubation at the right m1 segment of the mca resulted in an mtici score of 2a with no clot retrieval.Per the case report form (crf), no further passes were made.The two passes made with the embotrap iii device was made with an 8f flowgate2¿ balloon guide catheter (stryker), 0.061¿ axs catalyst¿ 6 da catheter (stryker) via a 0.021¿ trevo trak 21 microcatheter (stryker).There were no reported study device deficiencies.The final / end of the procedure mtici score was 2a.The patient¿s nihss score was 4 and mrs score was 3 on (b)(6) 2020.The patient was discharged to another hospital on (b)(6) 2020.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 25 january 2021.[additional event information]: on 25 january 2021, additional information was received from the clinical study team.The information indicated that the bleeding occurred during the second retraction of the embotrap iii device.The first pass / retraction of the embotrap iii device successfully reopened in a vessel with steep angle.The reason the use of the embotrap iii device as stopped after two passes was due to the bleeding, but this situation can happen with every stent retriever.It was confirmed that there was withdrawal difficulty during the use of the embotrap iii device, but this situation can happen with every stent retriever.The patient did well neurologically and on (b)(6) 2020, was released to another hospital to the normal cardiology ward.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 is to include the additional / modified event information received on (b)(6) 2021.[additional information]: on (b)(6) 2021, additional / modified information was received from the clinical study team.The information indicated that the reported adverse event term value ¿bleeding¿ was updated to ¿infra and supratentorielle sah.¿ the event resolved on (b)(6) 2020.Withdrawal difficulty from vessel, vessel perforation, and cerebral hemorrhage are well-known extensively documented potential complications associated with the use of the embotrap iii device in endovascular mechanical thrombectomy.With the information provided, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors, including clot burden/characteristics, vessel characteristics, tortuosity, device selection, and mechanical manipulation of devices within the artery, that may have contributed to the event rather than the design or manufacture of the device.The alleged withdrawal difficulty resulted in vessel perforation with consequent hemorrhage and the hemorrhage required surgical intervention to achieve hemostasis.Furthermore, the index procedure had to be aborted due to the event with final mtici score of 2a.Therefore, this event meets mdr reporting criteria as a ¿serious injury.¿ updated sections: g.3, g.6, h.2, h.6, and h.10.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 is to include the additional event information via source documents associated with the patient received on 20 july 2021.[additional event information]: on 20 july 2021, the source documents associated with the patient was received from the clinical study team.The information indicated that the patient was admitted from the hybrid operating room on (b)(6) 2020, after a transfemoral aortic valve replacement for severe aortic valve stenosis.The patient was initially admitted with syncope, bradyarrhythmia due to atrial fibrillation and a pre-existing left bundle branch block.After transfemoral aortic valve replacement (tavi) screening, the indication for valve replacement was made.According to the first report, the intervention was successful, and the bradycardic rhythm was the same as before the intervention.At admission, the patient was bradycardic, hypotensive, but subjectively symptom-free.During the course of further inpatient monitoring, there was a clear left-sided hemiparesis.Immediate cerebral computed tomography imaging (cct) was performed which revealed an occlusion of the right middle cerebral artery in the m1 flow area, which is why an immediate thrombectomy was performed.Due to accidental dissection, coiling of the vessel was also performed.Thereafter, there was a marked improvement of the symptoms in the left leg but a reduction in left arm strength persisted.Repeat cct was performed on the following day for further diagnosis.The imaging showed mild infra- and supratentorial subarachnoid hemorrhage (sah), otherwise with no change in findings compared to the previous examination.Following transfemoral aortic valve replacement and atrial fibrillation, therapeutic anticoagulation should be performed in principle.However, in the case of stroke, consultation with neurology and the valve team (senior physician) took place, and it was agreed that after the tavi, clopidogrel 75 mg/1x daily should be given in combination with thrombosis prophylaxis.Then a second cct should be performed on 09 november 2020, or at the beginning of the week.Based on this cct, the decision should be made whether to begin full anticoagulation with eliquis (mono).If this is possible, clopidogrel and the thrombosis prophylaxis can be discontinued.There is no new information that alters the previous file type determination and/or reportability determinations.Withdrawal difficulty from vessel, vessel dissection, and subarachnoid hemorrhage (sah) are well-known extensively documented potential complications associated with the use of the embotrap iii device in endovascular mechanical thrombectomy.With the information provided, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors including clot burden/characteristics, vessel characteristics, tortuosity, device selection, and mechanical manipulation of devices within the artery that may have contributed to the event rather than the design or manufacture of the device.The alleged withdrawal difficulty resulted in vessel dissection with sah which necessitated surgical intervention to achieve hemostasis.Furthermore, the index procedure had to be aborted due to the event with final mtici score of 2a.Therefore, this event meets mdr reporting criteria as a ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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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