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| Model Number ET009533 |
| Device Problem
Retraction Problem (1536)
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| Patient Problems
Hemorrhage, Cerebral (1889); Perforation of Vessels (2135); No Code Available (3191)
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| Event Date 03/16/2020 |
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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 identifier, weight, race, ethnicity, and medical history were not provided.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 and a follow-up mdr will be submitted upon completion of the device investigation.(b)(4).A review of the device history (dhr) records confirms that there were no issues with the assembly of the lot 19m037av (sub and top assembly).There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Withdrawal difficulty into intermediate catheter and vessel perforation requiring additional intervention are well-known potential procedural complications associated with the embotrap device.The root cause of the perforation could not be determined based on the available information and without procedural films to review; however, clinical and procedural factors including clot burden/characteristics, vessel characteristics, tortuosity, device selection, and operator technique are all factors that may have contributed.The ifu warns the user to not withdraw the embotrap device against significant resistance, and to assess the cause of the resistance using fluoroscopy.It also advises that if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.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 healthcare professional reported that during a mechanical thrombectomy procedure of a right internal carotid artery (ica) terminus/proximal middle cerebral artery (mca) occlusion with associated stroke in an (b)(6)-year-old female patient, a neuron¿ max guide catheter (penumbra) was used as the base catheter and placed in the right ica.A jet¿ 7 aspiration catheter (penumbra) was placed inside the neuron max guide catheter and brought to the face of the clot.Next, an excelsior® xt-27 microcatheter (stryker) was used to deliver the embotrap ii 5 x 33 revascularization device (et009533 / 19m037av); the microcatheter advanced past the clot and the embotrap ii device was delivered in accordance with the instructions for use (ifu).The embotrap ii device was then retrieved into the jet¿ 7 aspiration catheter; it was at this time that the physician encountered resistance while pulling the through the aspiration catheter.Once the physician was able to retrieve the embotrap ii device, he performed a vessel arteriogram which revealed a vessel injury / perforation.The physician removed the jet¿ 7 aspiration catheter and noted significant damage distally.The physician also examined both the excelsior® xt-27 microcatheter and the embotrap ii device and did not observed any device damage.The patient subsequently underwent arterial embolization to repair the vessel injury.The event did result in a procedural delay, but the duration of the delay was not documented on the complaint form.The complaint form also indicated that the original intent of the procedure changed due to the vessel perforation.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 6/5/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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 received on 5/19/2020.[conclusion]: the healthcare professional reported that during a mechanical thrombectomy procedure of a right internal carotid artery (ica) terminus/proximal middle cerebral artery (mca) occlusion with associated stroke in an 82-year-old female patient, a neuron¿ max guide catheter (penumbra) was used as the base catheter and placed in the right ica.A jet¿ 7 aspiration catheter (penumbra) was placed inside the neuron max guide catheter and brought to the face of the clot.Next, an excelsior® xt-27 microcatheter (stryker) was used to deliver the embotrap ii 5 x 33 revascularization device (et009533 / 19m037av); the microcatheter advanced past the clot and the embotrap ii device was delivered in accordance with the instructions for use (ifu).The embotrap ii device was then retrieved into the jet¿ 7 aspiration catheter; it was at this time that the physician encountered resistance while pulling the through the aspiration catheter.Once the physician was able to retrieve the embotrap ii device, he performed a vessel arteriogram which revealed a vessel injury / perforation.The physician removed the jet¿ 7 aspiration catheter and noted significant damage distally.The physician also examined both the excelsior® xt-27 microcatheter and the embotrap ii device and did not observed any device damage.The patient subsequently underwent arterial embolization to repair the vessel injury.The event did result in a procedural delay, but the duration of the delay was not documented on the complaint form.The complaint form also indicated that the original intent of the procedure changed due to the vessel perforation.Additional information was received on 5/19/2020.The patient suffered a right ica (cavernous segment) perforation and hemorrhage that required arterial embolization using neurovascular coils.The event resulted in prolongation of hospitalization.It was reported that the patient has been discharged from the hospital, but the date of patient discharge and patient disposition were not reported.The physician suspects that the jet¿ 7 aspiration catheter damage may have contributed to the vessel perforation.It was reported that the embotrap device was fully retracted into the intermediate catheter before withdrawal through the guide catheter.The distal tip to the jet 7 catheter was distal to the injury; the location of the guide catheter is unknown.This was the first and only pass made with the embotrap device.It is unknown if the entire clot was successfully removed.The embotrap device and the jet 7 catheter will be returned to penumbra for analysis first.Once penumbra completes the analyses of both devices, they will send the devices back to the hospital and the hospital will ship both devices to cerenovus for evaluation.It was reported that anonymized procedural images / angiographs are not available for review.Based on complaint information, the device is currently not available to be returned for analysis.A review of the device history (dhr) records confirms that there were no issues with the assembly of the lot 19m037av (sub and top assembly).There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The device has not been returned to cerenovus for analysis and therefore, no further investigation can be performed at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Withdrawal difficulty into intermediate catheter, vessel perforation, and hemorrhage requiring additional intervention are well-known potential procedural complications associated with the embotrap device.The root cause of the perforation could not be determined based on the available information and without procedural films to review; however, clinical and procedural factors including clot burden/characteristics, vessel characteristics, tortuosity, device selection, device interaction, and operator technique are all factors that may have contributed.The ifu warns the user to not withdraw the embotrap device against significant resistance, and to assess the cause of the resistance using fluoroscopy.It also advises that if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.It was reported that the embotrap and jet 7 will be returned for analysis; therefore, additional information may be available at a later date.With the information provided and without the product and concomitant microcatheter available for analyses, the reported customer complaint related to the malfunction of the embotrap could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.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.H.6: patient codes: the fda code: no code available fda 3191; c64343 was chosen to capture the prolongation of existing hospitalization.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 report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a mechanical thrombectomy procedure of a right internal carotid artery (ica) terminus/proximal middle cerebral artery (mca) occlusion with associated stroke in an 82-year-old female patient, a neuron¿ max guide catheter (penumbra) was used as the base catheter and placed in the right ica.A jet¿ 7 aspiration catheter (penumbra) was placed inside the neuron max guide catheter and brought to the face of the clot.Next, an excelsior® xt-27 microcatheter (stryker) was used to deliver the embotrap ii 5 x 33 revascularization device (et009533 / 19m037av); the microcatheter advanced past the clot and the embotrap ii device was delivered in accordance with the instructions for use (ifu).The embotrap ii device was then retrieved into the jet¿ 7 aspiration catheter; it was at this time that the physician encountered resistance while pulling the through the aspiration catheter.Once the physician was able to retrieve the embotrap ii device, he performed a vessel arteriogram which revealed a vessel injury / perforation.The physician removed the jet¿ 7 aspiration catheter and noted significant damage distally.The physician also examined both the excelsior® xt-27 microcatheter and the embotrap ii device and did not observed any device damage.The patient subsequently underwent arterial embolization to repair the vessel injury.The event did result in a procedural delay, but the duration of the delay was not documented on the complaint form.The complaint form also indicated that the original intent of the procedure changed due to the vessel perforation.Additional information was received on 5/19/2020.The patient suffered a right ica (cavernous segment) perforation and hemorrhage that required arterial embolization using neurovascular coils.The event resulted in prolongation of hospitalization.It was reported that the patient has been discharged from the hospital, but the date of discharge and the patient disposition were not reported.The physician suspects that the jet¿ 7 aspiration catheter damage may have contributed to the vessel perforation.It was reported that the embotrap device was fully retracted into the intermediate catheter before withdrawal through the guide catheter.The distal tip to the jet 7 catheter was distal to the injury; the location of the guide catheter is unknown.This was the first and only pass made with the embotrap device.It is unknown if the entire clot was successfully removed.The embotrap device and the jet 7 catheter will be returned to penumbra for analysis first.Once penumbra completes the analyses of both devices, they will send the devices back to the hospital and the hospital will ship both devices to cerenovus for evaluation.It was reported that anonymized procedural images / angiographs are not available for review.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the embotrap ii 5 x 33 revascularization device was received with its insertion tool.The original product packaging (i.E.Unit carton), hoop, tyvek pouch, and the instructions for use (ifu) were not returned.In addition, a jet 7 flex catheter was also returned with the embotrap ii device.Visual inspection prior to device decontamination was performed.Visual inspection of the distal end of the embotrap ii device (outer cage and inner channel components) indicated that there were stretching / separation to the proximal and distal coil.Visual and tactile inspection of the proximal portion of the device (i.E.The nitinol shaft) indicated no damage.The jet 7 flex catheter also underwent visual inspection; significant damage was noted to the distal end of the device with exposed wire at the distal tip and a very uneven surface along its distal end.Post-decontamination microscopic inspection was performed under magnification, all gold markers were intact without any damage observed on them.Microscopic examination of the proximal and distal spring coils indicated that there was deformation to both.The proximal end shows separation and unraveling, whereas on the distal end, there is bunching of the coil, an indication that there was a force applied on the coil in a proximal to distal direction.The separation on the proximal end of the distal coil is similar to the separation observed on the proximal coil.This deformation is consistent with the application of a force in a proximal to distal direction to the distal tip, and similar to deformation noted when the device is withdrawn through a reduced lumen such as when withdrawn through a closed rotating hemostasis valve (rhv).Inspection of the outer cage and inner channel under magnification was performed.No significant deformation was identified on the returned embotrap ii device.There were no strut fractures / kinks on any components.Visual inspection of the jet 7 flex catheter was performed.There was significant damage noted on the distal end of the catheter, the inner braid / coil structure was exposed due to the outer jacket / liner failure at approximately 30mm ¿ 35 mm from the distal end.An uneven surface all along the flexible distal 145mm length was observed, which is consistent with the application of a compressive force during use.In summary: the visual and microscopic inspection / examination of the returned embotrap ii device identified no significant deformation or damage of (outer cage and inner channel) the device and no evidence of any strut fractures, however, there was some deformation to the proximal and distal coil.The visual inspection also indicated that the return embotrap ii device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The returned embotrap ii device was successfully passed through a 0.0195¿ tube, confirming that the profile conformed to the specification for compatibility with 0.021¿ microcatheters.The returned insertion tool underwent dimensional verification and was confirmed that both inner diameter (id) and outer diameter (od) are within specifications.Functional evaluation: a flow model was set up using a merci 9f balloon guide catheter, a rebar 18 microcatheter, a jet 7 extra flex catheter (previously used in a bench simulation), and an embotrap ii device (lot#: 19k094av).The initial simulation was completed without clot present.There was no resistance noted upon the withdrawal of the embotrap ii device through the jet 7 catheter.A firm clot was introduced into the set up.An epic technique (gripping of the clot between the intermediate catheter tip and the embotrap) was attempted, however, the device failed to engage with the clot sufficiently to achieve the clot retrieval.Upon withdrawal of the embotrap ii device through the jet 7, there was no significant resistance noted, however, on further analysis, it was noted that the jet 7 catheter compressed and coiled during the withdrawal on the distal flexible end.This section of the catheter is the same region where the damage was noted on the returned unit.Upon inspection post-removal, a slight deformation was noted at approximately 30mm from the distal end in the coil.Another simulation was completed with the jet 7 and embotrap ii device using a larger, firmer clot.In this case, the epic technique was successfully employed, and in an attempt to recreate the damage, significant force was used to attempt to fully withdraw the embotrap ii and the jet 7 catheter through the guide catheter as in the procedure.Excessive compression and coil of the catheter along the flexible distal end of the catheter was noted.Upon removal of the catheter from the anatomical model, additional damage to the catheter in the same region (approximately 30mm from the distal end) was noted, and this deformation was noted to be consistent with the damage observed on the returned jet 7 flex catheter.The embotrap ii device and the jet 7 catheter were inspected post-simulated evaluation.The embotrap ii device showed evidence of deformation to the proximal coil that is consistent with the observed damage on the proximal coil of the returned embotrap ii device.The proximal coil of the embotrap ii device was in the distal 30mm section of the jet 7 catheter where the compression / coiling of the catheter occurred.The deformation of the catheter during the withdrawal is anticipated to reduce the catheter lumen, increasing the interaction on the catheter inner surface with the embotrap ii device, attempted withdrawal through such a reduced lumen may have caused the proximal coil of the embotrap ii device to be compressed.No distal tip damage was observed on the embotrap ii device.The jet 7 also exhibited similar deformation as observed on the returned jet 7 device along the distal 145mm of the catheter.Another attempt to replicate the more severe deformation as observed on the returned jet 7 catheter was recreated where greater withdrawal forces are applied in this manner could not be attempted, as on further evaluations as the jet 7 used in the above simulation could not be delivered to the target lesion due to the deformation created on the device during the second simulation.The deformation of the distal end of the jet 7 catheter compromised the column strength of the catheter (as the distal coil structure had experienced some separation of the coils) and the catheter would not track into the merci 9f balloon guide catheter.The complaint indicated that the embotrap ii device was returned due to the deformation noted to the jet 7 extra flex catheter.In the case the embotrap ii was retrieved through the jet 7 flex but the catheter experienced significant damage.This was noted upon completion of the procedure.The physician noted there was no significant resistance noted and this may be due to the flexibility and softness of the distal end of the jet 7 catheter.The damage to the return embotrap ii 5x33mm device proximal coil is indicative of a compressive force and likely occurred when excessive withdrawal force was used to retrieve the embotrap ii (probably with a large firm clot burden) through the jet 7 causing excessive angulation of the catheter, reducing the catheter inner diameter (id) and resulting in a compressive force to be applied to the proximal coil of the embotrap ii.The damage to the distal coil is consistent with withdrawing the embotrap ii device through a constricted lumen i.E.A closed rotating hemostasis valve (rhv), this may have occurred when the jet 7 catheter collapsed and the outer jacket failed causing permanent deformation and constriction of the catheter lumen and a minor tensile event at the embotrap ii distal tip.It is concluded that the damage to the embotrap ii device evident on the returned device was caused by the withdrawal of the device through the collapsed/deformed catheter id.This conclusion is supported by the recreation of an event where similar deformation to the catheter was caused by the attempted withdrawal of a large clot burden through the catheter using significant force, i.E.The damage to the proximal coil of the embotrap ii when withdrawing a large firm clot into the jet 7 catheter with excessive angulation and jacket deformation was noted in the same region as the returned device on the jet 7 catheter used on the bench simulation.Investigation conclusion: the returned embotrap ii exhibits characteristics which are consistent with a compressive force being subjected to the proximal coil due to excessive angulation of the catheter when a high force is used upon withdrawal with a large fibrin rich clot.The catheter returned demonstrated significant deformation.The concluded root causes for the difficulty experienced in retrieving the embotrap ii device through a jet 7 are the presence of a large firm fibrin clot which may have prevented the embotrap ii 5x33mm device withdrawing into the intermediate catheter, plugging the end of the jet 7 resulting in excessive compression / angulation of the distal end of catheter during withdrawal attempt(s).There is no indication that this complaint was as a result of a defect with the embotrap ii device.A review of the device history (dhr) records confirms that there were no issues with the assembly of the lot: 19m037av (sub and top assembly).There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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 of failure to detach was related to a manufacturing or design issue, no corrective actions will be taken at this time.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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