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

Model Number ET009533

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The product lot number was not reported initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

A report from the field indicated that during a mechanical thrombectomy procedure of an occlusion at the m1d, a concomitant microcatheter (marksman) was delivered to the m2 inferior branch and a 5x33 embotrap ii revascularization device (et009533, lot unknown) was deployed by unsheathing.After deployment, it was attempted to be retracted but it was too still to retract.It seemed to be ¿stuck¿.The microcatheter went up and the embotrap was re-sheathed and removed from the patient.After that, a microcatheter (3mm trevo, stryker) was used and reopening was obtained in a first passing of tici 2b.It was reported that the patient had severe tortuosity blood vessel and atherosclerosis.

Manufacturer Narrative

Product complaint #: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a report from the field indicated that during a mechanical thrombectomy procedure of an occlusion at the m1d, a concomitant microcatheter (marksman) was delivered to the m2 inferior branch and a 5x33 embotrap ii revascularization device (et009533, lot unknown) was deployed by unsheathing.After deployment, it was attempted to be retracted but it was too still to retract.It seemed to be ¿stuck¿.The microcatheter went up and the embotrap was re-sheathed and removed from the patient.After that, a microcatheter (3mm trevo, stryker) was used and reopening was obtained in a first passing of tici 2b.It was reported that the patient had severe tortuosity blood vessel and atherosclerosis.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.With the information available and without the product available for analysis, the reported customer complaint of ¿embotrap - withdrawal difficulty from vessel¿ could not be confirmed.Withdrawal difficulty from vessel is a potential complication associated with the use of the embotrap ii revascularization device in endovascular mechanical thrombectomy.The embotrap instructions for use (ifu) warns the user to never withdraw the device against significant resistance.Assess the cause of resistance using fluoroscopy and if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.With the amount of information available and without the device for analysis, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical, procedural factors, including vessel characteristics (severe tortuosity blood vessel and atherosclerosis), clot burden/characteristics, device interaction, device selection, and operator technique that may have contributed to the event.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.

Manufacturer Narrative

Product complaint #: (b)(4).Updated sections on this medwatch report: d4, e1, e2, e3, g3, g6, h2, h4 and h10.Section b5: additional information received indicated that the event did not result in thromboembolism.The withdrawal was performed as per the instructions for use (ifu).There was no vessel damage due to the event.Section e1: 1.Initial reporter phone (b)(6).Complaint conclusion updated with additional information received: a report from the field indicated that during a mechanical thrombectomy procedure of an occlusion at the m1d, a concomitant microcatheter (marksman) was delivered to the m2 inferior branch and a 5x33 embotrap ii revascularization device (et009533, 20d088av) was deployed by unsheathing.After deployment, it was attempted to be retracted but it was too still to retract.It seemed to be ¿stuck¿.The microcatheter went up and the embotrap was re-sheathed and removed from the patient.After that, a microcatheter (3mm trevo, stryker) was used and reopening was obtained in a first passing of tici 2b.It was reported that the patient had severe tortuosity blood vessel and atherosclerosis.Additional information received indicated that the event did not result in thromboembolism.The withdrawal was performed as per the instructions for use (ifu).There was no vessel damage due to the event.The device was discarded; therefore, no further investigation can be performed.A review of the manufacturing record evaluation (mre) associated with lot number lot# 20d088av presented no issues during the manufacturing or inspection process that can be related to the reported event.With the information available and without the product available for analysis, the reported customer complaint of ¿embotrap - withdrawal difficulty from vessel¿ could not be confirmed.Based on the mre, there is no indication that the event is related to the device manufacturing process.Withdrawal difficulty from the vessel is a potential complication associated with the use of the embotrap ii revascularization device in endovascular mechanical thrombectomy.The embotrap instructions for use (ifu) warns the user to never withdraw the device against significant resistance.Assess the cause of resistance using fluoroscopy and if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.With the amount of information available and without the device for analysis, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical, procedural factors, including vessel characteristics (severe tortuosity blood vessel and atherosclerosis), clot burden/characteristics, device interaction, device selection, and operator technique that may have contributed to the event.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.

• 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: 11170197
• MDR Text Key: 242169839
• Report Number: 3011370111-2021-00005
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 03/18/2021; 03/24/2020
• Supplement Dates FDA Received: 03/18/2021; 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1