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

Model Number ET009533

Device Problem Difficult to Remove (1528)

Patient Problems Paresis (1998); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during a thrombectomy procedure with the target occlusion at the distal m1 (m1d)-m2 of the middle cerebral artery (mca), the 5mm x 33mm embotrap ii revascularization device (et009533 / 20d088av) was used.An attempt was made to retract the device but resistance was felt and the embotrap ii device was not able to move.The device was removed and it was replaced with another catheter of small-diameter suction.It was reported that the procedure was completed with only the suction catheter.There was no report of any patient adverse event or complication.Additional information was received on 10 february 2021.The information indicated that the physician tried to retrieve the thrombus from the patient¿s vessel with the embotrap ii device, however, after trapping the thrombus, the embotrap ii device could not be withdrawn / pulled because the resistance was strong.Therefore, the microcatheter was returned slightly to the stent and the area where the stent was exposed was reduced, resulting in less resistance to facilitate the retrieval of the embotrap ii device.After that, a second pass was made and the vascular occlusion was opened to a tici of 2a.The procedure was then continued using the sofia¿ aspiration catheter (microvention-terumo) but there was no change in the occlusion, and the tici remained at 2a.The physician commented that the thrombus may have been ¿very hard.¿ since the microcatheter reached the periphery, the embotrap ii device was fully deployed into a small blood vessel, it may have been too closely attached and had high resistance.The patient did not have any bleeding, but the procedure ended with a tici of 2a.The patient was reported to have difficulty walking by him/herself.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (20d088av) 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.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Withdrawal difficulty and neurological impairment (hemiparesis) are well-known potential procedural complications associated with the embotrap revascularization device.The ifu also 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 event cannot be conclusively determined based on the information available for review; however, it is likely that clinical and procedural factors, including clot burden, vessel characteristics and excessive device manipulation, may have contributed.Review of the available information suggests that the event of difficulty walking (hemiparesis) is an expected evolution of the underlying disease process of acute ischemic stroke (ais).Since the outcome and severity of the actual event cannot be determined based on the information available for review, the event will be considered mdr reportable as a serious injury.With the limited information available and without the product available for analysis, the reported customer complaint cannot be confirmed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, characteristics of the thrombus / clot and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Based on the manufacturing documentation 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 during a thrombectomy procedure with the target occlusion at the distal m1 (m1d)-m2 of the middle cerebral artery (mca), the 5mm x 33mm embotrap ii revascularization device (et009533 / 20d088av) was used.An attempt was made to retract the device but resistance was felt and the embotrap ii device was not able to move.The device was removed and it was replaced with another catheter of small-diameter suction.It was reported that the procedure was completed with only the suction catheter.There was no report of any patient adverse event or complication.Additional information was received on 10 february 2021.The information indicated that the physician tried to retrieve the thrombus from the patient¿s vessel with the embotrap ii device, however, after trapping the thrombus, the embotrap ii device could not be withdrawn / pulled because the resistance was strong.Therefore, the microcatheter was returned slightly to the stent and the area where the stent was exposed was reduced, resulting in less resistance to facilitate the retrieval of the embotrap ii device.After that, a second pass was made and the vascular occlusion was opened to a tici of 2a.The procedure was then continued using the sofia¿ aspiration catheter (microvention-terumo) but there was no change in the occlusion, and the tici remained at 2a.The physician commented that the thrombus may have been ¿very hard.¿ since the microcatheter reached the periphery, the embotrap ii device was fully deployed into a small blood vessel, it may have been too closely attached and had high resistance.The patient did not have any bleeding, but the procedure ended with a tici of 2a.The patient was reported to have difficulty walking by him/herself.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to make a correction to the event coding and to the type of reportable event.[conclusion]: the healthcare professional reported that during a thrombectomy procedure with the target occlusion at the distal m1 (m1d)-m2 of the middle cerebral artery (mca), the 5mm x 33mm embotrap ii revascularization device (et009533 / 20d088av) was used.An attempt was made to retract the device but resistance was felt and the embotrap ii device was not able to move.The device was removed and it was replaced with another catheter of small-diameter suction.It was reported that the procedure was completed with only the suction catheter.There was no report of any patient adverse event or complication.Additional information was received on 10 february 2021.The information indicated that the physician tried to retrieve the thrombus from the patient¿s vessel with the embotrap ii device, however, after trapping the thrombus, the embotrap ii device could not be withdrawn / pulled because the resistance was strong.Therefore, the microcatheter was returned slightly to the stent and the area where the stent was exposed was reduced, resulting in less resistance to facilitate the retrieval of the embotrap ii device.After that, a second pass was made and the vascular occlusion was opened to a tici of 2a.The procedure was then continued using the sofia¿ aspiration catheter (microvention-terumo) but there was no change in the occlusion, and the tici remained at 2a.The physician commented that the thrombus may have been ¿very hard.¿ since the microcatheter reached the periphery, the embotrap ii device was fully deployed into a small blood vessel, it may have been too closely attached and had high resistance.The patient did not have any bleeding, but the procedure ended with a tici of 2a.The patient was reported to have difficulty walking by him/herself.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (20d088av) 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.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Withdrawal difficulty from vessel is a well-known potential procedural complication associated with the embotrap revascularization device.The ifu also 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 event cannot be conclusively determined based on the information available for review.However, there are clinical and procedural factors, including clot burden, vessel characteristics, device selection, and operator technique, that may have contributed rather than the design or manufacture of the device.Withdrawal difficulty from vessel meets mdr reporting criteria as a malfunction as it could 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.Treatment failure is a known potential outcome associated with endovascular mechanical thrombectomy.The root cause of the inability to achieve a mtici score of = 2b with three embotrap passes cannot be conclusively determined.However, there are clinical and procedural factors, including clot burden/characteristics, anatomical challenges, and operator technique, that may have contributed.Device ineffective with treatment failure does not meet mdr reporting criteria since the outcome (mtici score = 2a) is not related to a malfunction of the device but rather to the natural progression of the underlying disease process.With the limited information available and without the product available for analysis, the reported customer complaint cannot be confirmed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, characteristics of the thrombus / clot and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Based on the manufacturing documentation 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.H.1: type of reportable event: malfunction.H.6: health effect - clinical code: no clinical signs, symptoms or conditions.H.6: health effect - impact code: therapeutic response decreased.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 17 march 2021.E.1: initial reporter phone: (b)(6).[additional information]: the healthcare professional reported that during a thrombectomy procedure with the target occlusion at the distal m1 (m1d)-m2 of the middle cerebral artery (mca), the 5mm x 33mm embotrap ii revascularization device (et009533 / 20d088av) was used.An attempt was made to retract the device but resistance was felt and the embotrap ii device was not able to move.The device was removed and it was replaced with another catheter of small-diameter suction.It was reported that the procedure was completed with only the suction catheter.There was no report of any patient adverse event or complication.Additional information was received on 10 february 2021.The information indicated that the physician tried to retrieve the thrombus from the patient¿s vessel with the embotrap ii device, however, after trapping the thrombus, the embotrap ii device could not be withdrawn / pulled because the resistance was strong.Therefore, the microcatheter was returned slightly to the stent and the area where the stent was exposed was reduced, resulting in less resistance to facilitate the retrieval of the embotrap ii device.After that, a second pass was made and the vascular occlusion was opened to a tici of 2a.The procedure was then continued using the sofia¿ aspiration catheter (microvention-terumo) but there was no change in the occlusion, and the tici remained at 2a.The physician commented that the thrombus may have been ¿very hard.¿ since the microcatheter reached the periphery, the embotrap ii device was fully deployed into a small blood vessel, it may have been too closely attached and had high resistance.The patient did not have any bleeding, but the procedure ended with a tici of 2a.The patient was reported to have difficulty walking by him/herself.On 17 march 2021, additional information was received.The information indicated that lot number of the embotrap ii complaint device was confirmed as 20d088av.One pass had been made with the embotrap ii before the reported issue occurred.The final / end of procedure tici score was 2a, which was unchanged from baseline.It was reported that the device was prepped and used in accordance with the instructions for use (ifu).Withdrawal difficulty from vessel is a well-known potential procedural complication associated with the embotrap revascularization device.The ifu also 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 event cannot be conclusively determined based on the information available for review.However, there are clinical and procedural factors, including clot burden, vessel characteristics, device selection, and operator technique, that may have contributed rather than the design or manufacture of the device.Withdrawal difficulty from vessel meets mdr reporting criteria as a malfunction as it could 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.Treatment failure is a known potential outcome associated with endovascular mechanical thrombectomy.The root cause of the inability to achieve a mtici score of =2b with three embotrap passes cannot be conclusively determined.However, there are clinical and procedural factors, including clot burden/characteristics, anatomical challenges, and operator technique, that may have contributed.Device ineffective with treatment failure does not meet mdr reporting criteria since the outcome (mtici score =2a) is not related to a malfunction of the device but rather to the natural progression of the underlying disease process.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: 11334518
• MDR Text Key: 232323894
• Report Number: 3011370111-2021-00010
• 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
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2023
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 20D088AV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFIA¿ ASPIRATION CATHETER (MICROVENTION-TERUMO)
• Patient Outcome(s): Other