MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Model Number ET009533

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Vasoconstriction (2126)

Event Date 11/22/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (20b138av) 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.Arterial spasm, subarachnoid hemorrhage (sah), and withdrawal difficulty and are known potential complications associated with the embotrap revascularization device.Vessel spasm is a brief temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow distal to the spasm and may occur when positioning/advancing the devices through the vessel/arteries.This is a well-known potential complication with any invasive procedure during which devices are introduced into vessels.Details about the sequence of events leading up to the vasospasm were not reported, so it is not possible to conclusively determine the root cause of the event.Regarding the reported withdrawal difficulty, the ifu warns the user to not withdraw the device against significant resistance.The cause of the resistance should be assessed using fluoroscopy and the microcatheter should be advanced over the device to resheath or partially resheath to aid in withdrawal.The root cause of the events cannot be conclusively determined based on the information available for review; however, it is likely that pharmacological, clinical, and procedural factors, including vessel characteristics and excessive device manipulation, may have contributed.Withdrawal difficulty from the vessel is a mdr reportable malfunction and since the event required a medical intervention of creating an av shunt, the vasospasm was an intraprocedural finding, and the patient developed a sah which the relationship of the device to the reported events cannot be excluded, this event meets mdr reporting criteria as a ¿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.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.

Event Description

The healthcare professional reported that the patient underwent a mechanical thrombectomy procedure targeting an occlusion at the m1 segment of the middle cerebral artery (mca) using the 5mm x 33mm embotrap ii revascularization device (et009533 / 20b138av).It was reported that the embotrap ii device, the concomitant marksman¿ microcatheter (medtronic), and the ace¿ 68 reperfusion catheter (penumbra) were used in accordance with their respective instructions for use (ifu).The first pass was made with the embotrap ii device and the ace 68 catheter via the marksman microcatheter.It was reported that the microcatheter was delivered to the ¿md2¿ and the physician forcibly aligned the microcatheter with the thrombus proximally.(md2 is presumably a typo, and what is most likely meant is that the microcatheter was delivered to the m2 segment of the mca; since the thrombus is in the m1 segment, the physician would need to get past the clot to deploy the embotrap ii device).After the microcatheter was delivered, angiography imaging was taken, but it was reported that ¿there was an intense resistance felt as if trapped when pulling the stent.¿ after the stent was pulled, recanalization was not achieved.There are findings such as dissociation in the obstruction.The second pass was made with the same system and resistance was encountered.Then it was reported that ¿after removing the stent, the veins were visible, so an arteriovenous (av) shunt was created.¿ recanalization was still not achieved.The third pass was made with a solitaire¿ stent retriever (medtronic), the marksman microcatheter, and the ace 68 catheter.It was reported that ¿the patient seemed to have great pain,¿ but recanalization was achieved.There is no indication as to the exact point when the patient experienced pain during the procedure.After vessel recanalization was achieved, there was no bleeding and the clot was removed, and the procedure was completed.The physician commented that the reported event is related to the embotrap ii device.The procedure was successful after the embotrap ii device was replaced with the solitaire stent retriever and used on the same target lesion.On (b)(6) 2020, the sales representative provided additional information.It was reported that there was no problem with the acute ischemic stroke (ais) treatment.The patient is currently hospitalized with acute respiratory distress syndrome (ards) (acute respiratory failure).No additional treatment will be provided.Per the investigator, the event was not serious.For the ais treatment was resumed at tici score of 2b.Dynact showed minor subarachnoid hemorrhage (sah).There was intraoperative spasm and post-operative dynact showed only minor sah.Per the investigator, ¿this issue might have caused by different routes of the microcatheter.¿ on (b)(6) 2020, procedure notes were provided.The information is as followed: there was a right middle cerebral artery (mca) occlusion.Acute revascularization surgery was requested.The procedure was performed under tissue plasminogen activator (tpa) administration and under propofol sedation.A right transfemoral approach was made.A 9f long sheath was inserted into the right femoral artery (fa).Generalized heparin was administered.A 9f 90cm optimo balloon guiding catheter (tokai medical products) was inserted simultaneously with a jb2 soft (6f 125cm) and a 0.035/150cm excel med guidewire (aubex) was used; the tip of the optimo was placed at the origin of the right internal carotid artery (ica).Angiography showed an embolus in the middle of the m1 segment of the right mca.Simultaneous insertion of the ace¿ 68 reperfusion catheter, a 3.4fr/3.2fr 150cm tactics microcatheter (technocrat corporation), and a chikai 14 microguidewire (asahi intecc) was made.The ace 68 was placed at the right c4.The tactics microcatheter was replaced with the 2.8fr/3.2fr 150cm marksman microcatheter and inserted with the 200cm chikai 14 microguidewire.The microcatheter was placed in the m2 anterior trunk and the microguidewire was removed.The true lumen was confirmed by imaging from the microcatheter.The physician inserted the 5mm x 33mm embotrap ii revascularization device (et009533 / 20b138av); it was deployed from m2 to m1.The ace 68 catheter approached under the expansion of the optimo balloon guide catheter, while sucking with a 30ml back-lock syringe from pump suction from the ace 68 catheter and the optimo balloon guide catheter.The embotrap ii device and the ace 68 catheter were slowly retracted.Blood suction was almost stopped, but no thrombus adhered.The optimo balloon guide catheter was deflated after retrieval.Imaging showed no recanalization.Simultaneous insertion of the ace 68, the marksman microcatheter and the chikai 14 microguidewire were performed again and a microcatheter was placed in the m2 posterior trunk.The true lumen was confirmed by microcatheter imaging.The embotrap ii device was deployed from m2 to m1.As before, the embotrap and the ace 68 catheter were slowly retracted while performing the ace 68 and optimo balloon guide catheter suction.A white thrombus with a red thrombus were removed in the ace 68 catheter.The optimo balloon guide catheter was deflated after removal.Although recanalization of the m1 and m2 posterior trunk was confirmed by imaging, the obstruction in the middle / anterior trunk remained.The physician attempted recanalization.Simultaneous insertion of the ace 68 catheter, the marksman microcatheter and the chikai 14 microguidewire were done; the marksman was placed in the m2 anterior trunk.After true lumen was confirmed by imaging, a 4mm x 40mm solitaire¿ stent retriever (medtronic) was inserted and expanded from m2 to the distal m1.Then the solitaire stent retriever and the ace 68 were slowly retracted under aspiration of the ace 68 catheter and the optimo balloon guide catheter.No thrombus was found.Recanalization of the m2 middle trunk was confirmed by imaging but recanalization of the anterior trunk was not achieved.The procedure was terminated at this time due to concern for vascular injury.The final tici score was 2b.Imaging of the right neck showed no damage to the access route.Left common carotid angiography (ccag) was performed.The right m2 anterior trunk was visualized through the leptomeningeal anastomosis from the right anterior cerebral artery (aca) via the anterior communicating artery (acom).Dynact showed minor subarachnoid hemorrhage (sah).The sheath was not removed but was fixed and the physician left the room.The procedure was completed in 48 minutes from 6:50 pm to 7:38 pm.The final tici score was 2b.It was reported that it was a successful thrombus retrieval for the right mca occlusion.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional information received on 12 january 2021.The information provided are videos of the procedure.The videos underwent independent physician review on 13 january 2021.The result of the review is documented in this supplemental mdr.The above case description is accompanied by several videos of the case.The case involves revascularization of an ais secondary to an lvo of the right m1 mca.The embotrap ii device failed to achieve full recanalized the vessel after two attempts.The physician was able to recanalized the m1 and posterior m2.The anterior and middle m2 remained occlusive.The physician then chose to use solitaire and was able to recanalized the middle m2 division.The procedure was terminated at that point, with the anterior division m2 remaining occluded.There was a concern for vascular injury after the solitaire device, and that appears to be related to the solitaire, not the embotrap ii.There is no embotrap ii device malfunction that i can determine from this case, nor are there any performance issues related to the embotrap ii device from the information provided.Stroke cases are challenging cases and it is common to require multiple attempts to achieve full recanalization.Physician name and date reviewed: (b)(4), faans january 13, 2021.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to report that preliminary photos of the complaint device were captured by the j&j japan affiliates and included in the complaint file on 19 january 2021.[photo analysis]: preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file.The photos underwent review by the product analysis lab as documented below.The reported embotrap device was returned to johnson & johnson japan and photographs of the complaint device were taken.Examination of the photographs did not confirm any visual damage or deformation.The condition of the embotrap device cannot fully be confirmed based on the photographs received.Further investigation will be performed when the device is returned.A review of the manufacturing documentation associated with this lot (20b138av) 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.H.6: investigation findings / investigation conclusions: the ¿no device problem found¿ code was used in the investigational findings because based on the photos provided, no visual damage or deformation was observed.This code corresponds to the code ¿cause not established¿ code in the investigation conclusions.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 04 february 2021.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.

Manufacturer Narrative

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 the patient underwent a mechanical thrombectomy procedure targeting an occlusion at the m1 segment of the middle cerebral artery (mca) using the 5mm x 33mm embotrap ii revascularization device (et009533/20b138av).It was reported that the embotrap ii device, the concomitant marksman¿ microcatheter (medtronic), and the ace¿ 68 reperfusion catheter (penumbra) were used in accordance with their respective instructions for use (ifu).The first pass was made with the embotrap ii device and the ace 68 catheter via the marksman microcatheter.It was reported that the microcatheter was delivered to the ¿md2¿ and the physician forcibly aligned the microcatheter with the thrombus proximally.(md2 is presumably a typo, and what is most likely meant is that the microcatheter was delivered to the m2 segment of the mca; since the thrombus is in the m1 segment, the physician would need to get past the clot to deploy the embotrap ii device).After the microcatheter was delivered, angiography imaging was taken, but it was reported that ¿there was an intense resistance felt as if trapped when pulling the stent.¿ after the stent was pulled, recanalization was not achieved.There are findings such as dissociation in the obstruction.The second pass was made with the same system and resistance was encountered.Then it was reported that ¿after removing the stent, the veins were visible, so an arteriovenous (av) shunt was created.¿ recanalization was still not achieved.The third pass was made with a solitaire¿ stent retriever (medtronic), the marksman microcatheter, and the ace 68 catheter.It was reported that ¿the patient seemed to have great pain,¿ but recanalization was achieved.There is no indication as to the exact point when the patient experienced pain during the procedure.After vessel recanalization was achieved, there was no bleeding and the clot was removed, and the procedure was completed.The physician commented that the reported event is related to the embotrap ii device.The procedure was successful after the embotrap ii device was replaced with the solitaire stent retriever and used on the same target lesion.On 28 december 2020, the sales representative provided additional information.It was reported that there was no problem with the acute ischemic stroke (ais) treatment.The patient is currently hospitalized with acute respiratory distress syndrome (ards) (acute respiratory failure).No additional treatment will be provided.Per the investigator, the event was not serious.For the ais treatment was resumed at tici score of 2b.Dynact showed minor subarachnoid hemorrhage (sah).There was intraoperative spasm and post-operative dynact showed only minor sah.Per the investigator, ¿this issue might have caused by different routes of the microcatheter.¿ on 29 december 2020, procedure notes were provided.The information is as followed: there was a right middle cerebral artery (mca) occlusion.Acute revascularization surgery was requested.The procedure was performed under tissue plasminogen activator (tpa) administration and under propofol sedation.A right transfemoral approach was made.A 9f long sheath was inserted into the right femoral artery (fa).Generalized heparin was administered.A 9f 90cm optimo balloon guiding catheter (tokai medical products) was inserted simultaneously with a jb2 soft (6f 125cm) and a 0.035/150cm excel med guidewire (aubex) was used; the tip of the optimo was placed at the origin of the right internal carotid artery (ica).Angiography showed an embolus in the middle of the m1 segment of the right mca.Simultaneous insertion of the ace¿ 68 reperfusion catheter, a 3.4fr/3.2fr 150cm tactics microcatheter (technocrat corporation), and a chikai 14 microguidewire (asahi intecc) was made.The ace 68 was placed at the right c4.The tactics microcatheter was replaced with the 2.8fr/3.2fr 150cm marksman microcatheter and inserted with the 200cm chikai 14 microguidewire.The microcatheter was placed in the m2 anterior trunk and the microguidewire was removed.The true lumen was confirmed by imaging from the microcatheter.The physician inserted the 5mm x 33mm embotrap ii revascularization device (et009533/20b138av); it was deployed from m2 to m1.The ace 68 catheter approached under the expansion of the optimo balloon guide catheter, while sucking with a 30ml back-lock syringe from pump suction from the ace 68 catheter and the optimo balloon guide catheter.The embotrap ii device and the ace 68 catheter were slowly retracted.Blood suction was almost stopped, but no thrombus adhered.The optimo balloon guide catheter was deflated after retrieval.Imaging showed no recanalization.Simultaneous insertion of the ace 68, the marksman microcatheter and the chikai 14 microguidewire were performed again and a microcatheter was placed in the m2 posterior trunk.The true lumen was confirmed by microcatheter imaging.The embotrap ii device was deployed from m2 to m1.As before, the embotrap and the ace 68 catheter were slowly retracted while performing the ace 68 and optimo balloon guide catheter suction.A white thrombus with a red thrombus were removed in the ace 68 catheter.The optimo balloon guide catheter was deflated after removal.Although recanalization of the m1 and m2 posterior trunk was confirmed by imaging, the obstruction in the middle/anterior trunk remained.The physician attempted recanalization.Simultaneous insertion of the ace 68 catheter, the marksman microcatheter and the chikai 14 microguidewire were done; the marksman was placed in the m2 anterior trunk.After true lumen was confirmed by imaging, a 4mm x 40mm solitaire¿ stent retriever (medtronic) was inserted and expanded from m2 to the distal m1.Then the solitaire stent retriever and the ace 68 were slowly retracted under aspiration of the ace 68 catheter and the optimo balloon guide catheter.No thrombus was found.Recanalization of the m2 middle trunk was confirmed by imaging but recanalization of the anterior trunk was not achieved.The procedure was terminated at this time due to concern for vascular injury.The final tici score was 2b.Imaging of the right neck showed no damage to the access route.Left common carotid angiography (ccag) was performed.The right m2 anterior trunk was visualized through the leptomeningeal anastomosis from the right anterior cerebral artery (aca) via the anterior communicating artery (acom).Dynact showed minor subarachnoid hemorrhage (sah).The sheath was not removed but was fixed and the physician left the room.The procedure was completed in 48 minutes from 6:50 pm to 7:38 pm.The final tici score was 2b.It was reported that it was a successful thrombus retrieval for the right mca occlusion.Additional information received on 12 january 2021.The information provided are videos of the procedure.The videos underwent independent physician review on (b)(6) 2021.The above case description is accompanied by several videos of the case.The case involves revascularization of an ais secondary to an lvo of the right m1 mca.The embotrap ii device failed to achieve full recanalized the vessel after two attempts.The physician was able to recanalized the m1 and posterior m2.The anterior and middle m2 remained occlusive.The physician then chose to use solitaire and was able to recanalized the middle m2 division.The procedure was terminated at that point, with the anterior division m2 remaining occluded.There was a concern for vascular injury after the solitaire device, and that appears to be related to the solitaire, not the embotrap ii.There is no embotrap ii device malfunction that i can determine from this case, nor are there any performance issues related to the embotrap ii device from the information provided.Stroke cases are challenging cases and it is common to require multiple attempts to achieve full recanalization.Physician name and date reviewed: (b)(6) and (b)(6) 2021.Arterial spasm, subarachnoid hemorrhage (sah), and withdrawal difficulty and are known potential complications associated with the embotrap revascularization device.Vessel spasm is a brief temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow distal to the spasm and may occur when positioning/advancing the devices through the vessel/arteries.This is a well-known potential complication with any invasive procedure during which devices are introduced into vessels.Details about the sequence of events leading up to the vasospasm were not reported, so it is not possible to conclusively determine the root cause of the event.Regarding the reported withdrawal difficulty, the ifu warns the user to not withdraw the device against significant resistance.The cause of the resistance should be assessed using fluoroscopy and the microcatheter should be advanced over the device to resheath or partially resheath to aid in withdrawal.The root cause of the events cannot be conclusively determined based on the information available for review; however, it is likely that pharmacological, clinical, and procedural factors, including vessel characteristics and excessive device manipulation, may have contributed.Withdrawal difficulty from the vessel is a mdr reportable malfunction and since the event required a medical intervention of creating an av shunt, the vasospasm was an intraprocedural finding, and the patient developed a sah which the relationship of the device to the reported events cannot be excluded, this event meets mdr reporting criteria as a ¿serious injury.¿ preliminary photos of the complaint device were captured by the j&j japan affiliates and included in the complaint file on (b)(6) 2021.[photo analysis]: preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file.The photos underwent review by the product analysis lab as documented below.The reported embotrap device was returned to johnson & johnson japan and photographs of the complaint device were taken.Examination of the photographs did not confirm any visual damage or deformation.The condition of the embotrap device cannot fully be confirmed based on the photographs received.The complaint device was returned for evaluation and analysis.The product investigation was started on (b)(6) 2021 and has been completed on (b)(6) 2021; the investigation is documented below.Investigation summary: it was reported by the customer that the physician felt a strong resistance during attempting to withdraw the embotrap ii device.The microcatheter was able to cover the half portion of the embotrap ii device and the embotrap ii device could be withdrawn successfully.It was confirmed during the 2nd pass that a white thrombus with a red thrombus was removed by the aspiration via the ace 68 intermediate catheter.The visual inspection of the returned embotrap ii device, under magnification, indicated a coil kink on the proximal segment of the distal coil and a strut kink on the distal segment of the outer cage.There was no other significant deformation or damage noted on the returned embotrap ii device.There was no evidence of any strut fractures.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 simulated withdrawal of the returned embotrap ii device exhibited no issues upon advancement through the sample headway 21 microcatheter, deployment distal to the microcatheter and withdrawal to the sample ace 68 intermediate catheter.No significant resistance to withdrawal was noted during this simulation.This indicates that the returned embotrap ii device performs as intended.A review of the manufacturing documentation associated with this lot (20b138av) 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.Investigation conclusion: based on the investigation performed on the returned embotrap ii device, it is concluded that the returned embotrap ii device performs as intended and therefore is not the cause of the resistance during the withdrawal of embotrap ii device noted by the physician.Investigation of the returned embotrap ii device could not determine a device malfunction.Where the device performs as intended, the potential causes of difficulties in withdrawal are due to, but not limited to: withdrawal of a large or a hard clot burden with the embotrap ii device, resulting in resistance when withdrawing the embotrap ii device from the vessel and into an intermediate/guide catheter.This is supported by the provided information from the customer that a white thrombus with a red thrombus was removed by the aspiration via the ace 68 intermediate catheter.Tortuosity of the patient anatomy/vessel and/or possible underlying disease state, e.G.Atherosclerosis.Intraoperative spasm potentially occurred during withdrawal of the embotrap ii device.The various procedural and anatomic factors can affect the outcome of the procedure, and the exact cause of the encountered withdrawal difficulties could not be determined.There is no indication that this complaint was as a result of a defect with the embotrap ii device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.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.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3; ballybritt business park; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 11090844
• MDR Text Key: 231786452
• Report Number: 3011370111-2020-00099
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2023
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 20B138AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/12/2021; 01/19/2021; 02/04/2021; 02/17/2021
• Supplement Dates FDA Received: 01/14/2021; 01/22/2021; 02/04/2021; 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.035/150CM EXCEL MED GUIDEWIRE (AUBEX); 30-ML BACK-LOCK SYRINGE (UNKNOWN BRAND); 9F OPTIMO BALLOON GUIDING CATHETER (TOKAI); ACE¿ 68 REPERFUSION CATHETER (PENUMBRA); CHIKAI 14 MICROGUIDEWIRE (ASAHI INTECC); MARKSMAN¿ MICROCATHETER (MEDTRONIC); SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC); TACTICS MICROCATHETER (TECHNOCRAT CORPORATION)
• Patient Outcome(s): Required Intervention