MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309537

Device Problems Break (1069); Patient-Device Incompatibility (2682)

Patient Problems Intracranial Hemorrhage (1891); Thromboembolism (2654)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Lot: the lot number was not reported.Initial reporter phone: (b)(6).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00410.Complaint conclusion: as reported by the field, during a mechanical thrombectomy for occlusion located at the m1 segment of the middle cerebral artery (mca), a 5mm x 37mm embotrap iii revascularization device (et309537, lot unknown), and an embovac aspiration catheter (unknown product/lot) were used.The thrombus was not able to be removed with second passe at m2 obstruction.During the third attempt, it might have been damaged by the microcatheter, and an embolic in new territory occurred.The procedure was terminated.It is unknown if it is an influence of a microguidewire (mgw) or a stent, but subarachnoid hemorrhage (sah) occurred after the procedure.The stent and a dac were easy to deliver and deploy.The bleeding occurred from the stent use.A continuous flush was done.Concomitant devices are unknown.The complaint will be reassessed if additional information becomes available.Additional information was received indicating that anonymized images/angiographs of the procedure are not available.The embotrap¿s and embovac¿s lot numbers are not available.The physician stated that the cause of the sah may have been the micro guide wire or the stent (he did not specify if it was the embotrap device).There was no alleged product malfunction with the embovac.The size and brand of the microwire was not available.There was no further information available about the cause of the bleed, whether the bleed was secondary to a vascular injury, whether any medical intervention was performed, when the bleed was noticed after the procedure, the clot characteristics, whether there any device malfunctions or performance issues such as resistance upon withdrawal issues associated with the embotrap iii device.There was also no further information available about the brand of the distal catheter that was used, the current status of the patient, the patient¿s baseline neurological condition, if the event led to permanent deficits or residual neurological deficits and the patient¿s nihss/mrs scores.There was also no further information available on whether the event led to prolongation of hospitalization or the patient¿s demographic information.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.Subarachnoid hemorrhage & thromboembolism are known potential complications associated with the use of the embotrap device in mechanical thrombectomy procedures.During these interventional procedures, the devices are advanced and withdrawn through pre-existing thrombotic lesions with the risk of embolization of thrombus.Clinical and procedural factors including clot burden, vessel characteristics, and operator technique, may have contributed to these events.With the information available and without the product available for analysis, the reported customer complaint of cage assembly damaged in patient could not be confirmed.The damaged-in patient (cage assembly) could have compromised the integrity of the basket or decreased the effectiveness of the device, and a damaged basket could result in vessel damage and/or the release of emboli and subsequent ischemia or infarct.Therefore, this event meets mdr reporting criteria.The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.

Event Description

As reported by the field, during a mechanical thrombectomy for occlusion located at the m1 segment of the middle cerebral artery (mca), a 5mm x 37mm embotrap iii revascularization device (et309537, lot unknown), and an embovac aspiration catheter (unknown product/lot) were used.The thrombus was not able to be removed with second passe at m2 obstruction.During the third attempt, it might have been damaged by the microcatheter, and an embolic in new territory occurred.The procedure was terminated.It is unknown if it is an influence of a microguidewire (mgw) or a stent, but subarachnoid hemorrhage (sah) occurred after the procedure.The stent and a dac were easy to deliver and deploy.The bleeding occurred from the stent use.A continuous flush was done.Concomitant devices are unknown.Additional information received on 31-may-2022 indicated that the anonymized images/angiographs of the procedure are not available.The embotrap¿s and embovac¿s lot numbers are not available.The physician stated that the cause of the sah may have been the micro guide wire or the stent (he did not specify if it was the embotrap device).There was no alleged product malfunction with the embovac.The size and brand of the microwire was not available.There was no further information available about the cause of the bleed, whether the bleed was secondary to a vascular injury, whether any medical intervention was performed, when the bleed was noticed after the procedure, the clot characteristics, whether there any device malfunctions or performance issues such as resistance upon withdrawal issues associated with the embotrap iii device.There was also no further information available about the brand of the distal catheter that was used, the current status of the patient, the patient¿s baseline neurological condition, if the event led to permanent deficits or residual neurological deficits and the patient¿s nihss/mrs scores.There was also no further information available on whether the event led to prolongation of hospitalization or the patient¿s demographic information.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: section b5: additional information received on 14-jun-2022 indicated that a spinal drain was implanted after the procedure and neurological symptoms are improving.The symptoms did not seem related to subarachnoid hemorrhage (sah) but seemed related to the original symptoms.There was no reported complaint regarding the products.It is possible that the embotrap was damaged by the microcatheter, but the details are unknown.A chikai microwire was used during the procedure.It may have been struck by the mgw or it may have pulled the stent, causing the bleed, but the details are unknown.Bleeding was due to vascular injury and a spinal drain was implanted.Bleeding was noticed immediately after the procedure, but there was no alleged device malfunction associated with the embotrap iii device.Improvement was seen the day after the operation.There was neurological symptom(s) present, but they were not due to bleeding.It¿s possible these neurological symptoms (s) were present before the event.No sequelae were reported.It¿s unknown if the event caused prolonged hospitalization.Based on the additional information received, the medical device problem code break (a0401) previously reported no longer applies as there was no alleged product malfunction against the involved device.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EMBOTRAP III 5 MM X 37 MM
• Type of Device: EMBOTRAP III REVASCULARIZATION DEVICE
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt; business park; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14643597
• MDR Text Key: 293655673
• Report Number: 3011370111-2022-00055
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: 10886704084570
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 135CM EMBOVAC 71 ASP. CATHETER; UNSPECIFIED MICRO GUIDE WIRE; UNSPECIFIED MICROCATHETER