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

Model Number	ET009533
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Date of event: the date of the event was not reported.Lot: not available at time of report initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
It was reported by a healthcare professional that during a mechanical thrombectomy of a middle cerebral artery (mca) (m3 segment) occlusion, the physician encountered difficulty withdrawing the 5mm x 3mm embotrap ii revascularization device (et009533/unknown lot number) from the patient.Extravasation occurred as a result of the event.The extravasation was treated with hemostatic medicine and blood pressure control.The event did not lead to prolonged hospitalization.The physician stated that ¿because it was developed in m3, the blood vessel used was not appropriate.The patient had paralysis at baseline, and the extravasation did not affect the patient¿s clinical outcome.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date of event: the date of the event was not reported.Lot: not available at time of report initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
It was reported by a healthcare professional that during a mechanical thrombectomy of a middle cerebral artery (mca) (m3 segment) occlusion, the physician encountered difficulty withdrawing the 5mm x 3mm embotrap ii revascularization device (et009533/unknown lot number) from the patient.Extravasation occurred as a result of the event.The extravasation was treated with hemostatic medicine and blood pressure control.The event did not lead to prolonged hospitalization.The physician stated that ¿because it was developed in m3, the blood vessel used was not appropriate.The patient had paralysis at baseline, and the extravasation did not affect the patient¿s clinical outcome.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section e1.Initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional that during a mechanical thrombectomy of a middle cerebral artery (mca) (m3 segment) occlusion, the physician encountered difficulty withdrawing the 5mm x 3mm embotrap ii revascularization device (et009533/unknown lot number) from the patient.Extravasation occurred as a result of the event.The extravasation was treated with hemostatic medicine and blood pressure control.The event did not lead to prolonged hospitalization.The physician stated that ¿because it was developed in m3, the blood vessel used was not appropriate.The patient had paralysis at baseline, and the extravasation did not affect the patient¿s clinical outcome.No further information was provided.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.Withdrawal difficulty from vessel and hemorrhage secondary to vascular injury are well-known potential complications associated with the use of the embotrap ii revascularization device in mechanical thrombectomy procedures.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are patient and procedural factors including vessel characteristics, clot burden, device selection, and mechanical manipulation of devices within the artery that may have contributed to the event rather than the design or manufacture of the device.The complaint report indicates that the blood vessel being treated was not appropriate (i.E., m3 segment).Per the embotrap ii instructions for use (ifu): the embotrap ii revascularization device (hereafter referred to as the embotrap ii device) is designed for use in the anterior and posterior neurovasculature in vessels such as the internal carotid artery, the m1 or m2 segments of the middle cerebral artery, and basilar arteries (vessel sizes ranging from 1.5 to 5.0 mm).The alleged withdrawal difficulty appears to have resulted in vascular injury with sah with the need for medical intervention.The file will be re-reviewed if additional information is received at a later date.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.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12961830
• Report Number: 3011370111-2021-00158
• Device Sequence Number: 20192867
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown