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| Catalog Number ET309645 |
| Device Problems
Fracture (1260); Difficult to Remove (1528); Lack of Effect (4065)
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| Patient Problem
Insufficient Information (4580)
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| Event Date 02/15/2024 |
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Event Type
Death
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Manufacturer Narrative
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Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section b2 ¿ date of death: the date of the death was not reported.Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Withdrawal difficulty of the embotrap device through the vessel could require increased force, which can result in vessel trauma, vessel spasm, damage to the basket with the potential for release of emboli and subsequent ischemia or infarct and/or the need for additional intervention.In this case, there were no reports of vascular injury, however, a piece of the strut separated upon removal and was left in the patient.Separation of the strut can lead to vessel damage, embolization, ischemia, or infarct, and/or the need for additional intervention.In addition, the embotrap device was unable to remove the target thrombus from the treated vessel after 3 passes, which in this case, could be related to the device malfunction: the risk of re-accessing the vessel, with a component of the embotrap device left in the vessel, can potentially outweigh the benefits of recanalization, as further manipulation within the vessel can increase the risk for vessel damage.Per the additional information received on 22-feb-2024, 23-feb-2024, and the assessment from the medical safety officer (mso) received on 28-feb-2024, the patient expired at some point after the initial event was reported.The events leading up to the death are unknown.If it unclear if the events of treatment failure and/or device separation -in patient, may have contributed to the outcome of death.Further investigation will be conducted, however, at this time, the event will be conservatively reported to the us fda under reporting criteria 21 cfr 803, with the classification of ¿death,¿ with an awareness date of 22-feb-2024.The file will be re-reviewed if additional information is received at a later date.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.
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Event Description
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It was reported, via electronic mail, that an embotrap iii 6.5 mm x 45 mm (et309645/23j079av) was used for a mechanical thrombectomy procedure for an occlusion at the middle cerebral artery (mca).During the procedure, the user reported treatment failure, withdrawal difficulty from the vessel, and strut separation in-patient.The event was reported as such, ¿during a mechanical thrombectomy procedure, doctor used an embotrap iii 6.5x45mm in the patient¿s occluded mca.Other devices used in the procedure included a 6f setup including a penumbra red 72 catheter with ¿send it¿ as well as a velocity microcatheter.There were three passes made using the embotrap iii 6.5x45mm and on the third attempt when withdrawing the embotrap the device resisted being removed and appeared to be stuck somewhere in the vessel.Using a velocity microcatheter and the embotrap iii, the device was removed from the patient however a part of the embotrap device broke off and remains in the patient¿s mca.The occluded vessel wasn¿t able to be recanalized.The embotrap device was retained by the hospital and will be returned to cerenovus next week.¿ the device will be returned for further analysis.The outcome of the patient is unknown.Additional information was received on 22-feb-2024.Summary: per the information, it was reported that the device ¿broke off¿ in the m1 segment of the middle cerebral artery (mca).Regarding the vessel and thrombus characteristics, it was said the vessel was ¿fairly tortuous but not extreme, the clot was firm and organized.¿ regarding if the cause of the resistance confirmed on angiogram, it was said, ¿it was not confirmed where the resistance came from.The red 72 with send it technology also broke off in the vessel.It was retrieved with a snare.¿ it is unknown if any additional diagnostic exams or medication/treatments were done for the patient.Regarding the patient¿s current status, it was disclosed that the ¿85-year-old male patient died as a result of the stroke.¿ concomitant devices did not perform as intended, as the ¿red72 catheter broke off in the patient.¿ additional information was received on 23-feb-2024.Summary: per the information provided, there were three passes made in total during the procedure.Regarding whether the physician felt they could not do any additional retrieval attempts after the embotrap broke off and was left in patient, it was said, ¿the catheter tip of the red 72 broke off at the same time the embotrap broke off.A snare was used to remove the catheter tip.¿ the physician was not sure why the catheter tip broke off the red72.In response to which component of the embotrap ¿broke off," it was reported, ¿the embotrap looks like it separated at the distal end of the delivery wire, at proximal portion of the first cage.The product being turned in looks like the proximal 20mm platinum coil is unwound.¿ no patient medical history, baseline nihss/mrs assessment scores, nor date of death, could be obtained at this time.
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Manufacturer Narrative
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Product complaint # (b)(4).Complaint conclusion: it was reported, via electronic mail, that an embotrap iii 6.5 mm x 45 mm (et309645/23j079av) was used for a mechanical thrombectomy procedure for an occlusion at the middle cerebral artery (mca).During the procedure, the user reported treatment failure, withdrawal difficulty from the vessel, and strut separation in-patient.The event was reported as such, ¿during a mechanical thrombectomy procedure, doctor used an embotrap iii 6.5x45mm in the patient¿s occluded mca.Other devices used in the procedure included a 6f setup including a penumbra red 72 catheter with ¿sendit¿ as well as a velocity microcatheter.There were three passes made using the embotrap iii 6.5x45mm and on the third attempt when withdrawing the embotrap the device resisted being removed and appeared to be stuck somewhere in the vessel.Using a velocity microcatheter and the embotrap iii, the device was removed from the patient however a part of the embotrap device broke off and remains in the patient¿s mca.The occluded vessel wasn¿t able to be recanalized.The outcome of the patient is unknown.Additional information was received on 22-feb-2024.Summary: per the information, it was reported that the device ¿broke off¿ in the m1 segment of the middle cerebral artery (mca).Regarding the vessel and thrombus characteristics, it was said the vessel was ¿fairly tortuous but not extreme, the clot was firm and organized.¿ regarding if the cause of the resistance confirmed on angiogram, it was said, ¿it was not confirmed where the resistance came from.The red 72 with send it technology also broke off in the vessel.It was retrieved with a snare.¿ it is unknown if any additional diagnostic exams or medication/treatments were done for the patient.Regarding the patient¿s current status, it was disclosed that the ¿85-year-old male patient died as a result of the stroke.¿ concomitant devices did not perform as intended, as the ¿red72 catheter broke off in the patient.¿ additional information was received on 23-feb-2024.Summary: per the information provided, there were three passes made in total during the procedure.Regarding whether the physician felt they could not do any additional retrieval attempts after the embotrap broke off and was left in patient, it was said, ¿the catheter tip of the red 72 broke off at the same time the embotrap broke off.A snare was used to remove the catheter tip.¿ the physician was not sure why the catheter tip broke off the red72.In response to which component of the embotrap ¿broke off," it was reported, ¿the embotrap looks like it separated at the distal end of the delivery wire, at proximal portion of the first cage.The product being turned in looks like the proximal 20mm platinum coil is unwound.¿ no patient medical history, baseline nihss/mrs assessment scores, nor date of death, could be obtained at this time.The medical imaging was reviewed by cerenovus sr.Medical affairs director, and the assessment reads as follows: ¿the case description is clear and supported by the three images provided.These are unsubtracted images showing the embotrap being fixed in the distal territory and collapsed/stretched in the proximal third of the device.There is a visible damage to the conduit device proximally, showing that there are high forces in play.The column of contrast stasis in the second image suggests a distal occlusion.This can either be due to the clot burden, obstruction due to the pulling on the device, or local vasospasm.The latter could also be considered the reason for the failure to retrieve either of the devices from the vasculature, especially given the non-direct interaction of the red72 with sendit with the clot.Further analysis of the devices is recommended¿.Notes: separation of nitinol shaft occurred approximately 30 mm from head of shaft.Examination of the returned embotrap device identified damage and fracturing of the embotrap nitinol shaft component.The proximal coil and stent assembly (outer cage, inner channel and distal coil) were not present on the returned device.Visual inspection under magnification of the fracture point of the nitinol shaft showed signs of narrowing and necking in the region of the failure where plastic deformation of the shaft occurred prior to failure.The appearance of the fracture is consistent with a material under tension.Sem analysis of the appearance of the fracture face also confirmed that the fracture is consistent with a material under tension.There was no evidence of a material fault which would result in lower than anticipated tensile load failure.It is unknown what caused resistance on device withdrawal on the third pass.Based on the provided fluoroscopy images, the evidence of the returned embotrap device shaft and red72 catheter material, it is likely that extreme forces were in play.Potential cause of the complaint event is local vasospasm combined with tortuous anatomy, contributing to device resistance on withdrawal and resulting in device separation.The estimated force required to break the shaft at the approximate location observed on the complaint device was calculated to be 31.7n.A recreation of the shaft failure was performed by tensile testing a sample embotrap iii shaft.It was confirmed that 33.5n force is required to break the shaft at the approximate position observed on the returned device.Tensile forces of this magnitude are extreme and beyond clinical use.A device history review (dhr) associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.While the complaint event is confirmed, the root cause could not be determined.There is no indication that this complaint was as a result of a defect with the embotrap device.Withdrawal difficulty of the embotrap device through the vessel could require increased force, which can result in vessel trauma, vessel spasm, damage to the basket with the potential for release of emboli and subsequent ischemia or infarct and/or the need for additional intervention.In this case, there were no reports of vascular injury, however, a piece of the strut separated upon removal and was left in the patient.Separation of the strut can lead to vessel damage, embolization, ischemia, or infarct, and/or the need for additional intervention.In addition, the embotrap device was unable to remove the target thrombus from the treated vessel after 3 passes, which in this case, could be related to the device malfunction: the risk of re-accessing the vessel, with a component of the embotrap device left in the vessel, can potentially outweigh the benefits of recanalization, as further manipulation within the vessel can increase the risk for vessel damage.Per the additional information received on 22-feb-2024, 23-feb-2024, and the assessment from the medical safety officer (mso) received on 28-feb-2024, the patient expired at some point after the initial event was reported.The events leading up to the death are unknown.If it unclear if the events of treatment failure and/or device separation -in patient, may have contributed to the outcome of death.Further investigation will be conducted, however, at this time, the event will be conservatively reported to the us fda under reporting criteria 21 cfr 803, with the classification of ¿death,¿ with an awareness date of 22-feb-2024.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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