MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; CATHETER, THROMBUS RETRIEVER

Catalog Number ET307645

Device Problem Difficult to Remove (1528)

Patient Problem Vasoconstriction (2126)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: a report from the field indicated that during a mechanical thrombectomy of a distal internal carotid artery (ica)-middle cerebral artery (mca) (m1 segment) occlusion, the physician found the 6.5mm x 45mm embotrap iii (et307645/unknown lot number) revascularization device was rather stiff and spasm-inducing.He also had trouble retrieving the device from the patient and felt that it was a ¿totally different device from the 5mm¿.The physician further stated that he knows the device can be used in vessels 1.5mm in diameter, but he will not be using it in vessels ¿even twice that size¿.No further information is available.The device was not returned for analysis and 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 is a known potential procedural complication associated with the embotrap device.The embotrap iii instructions for use (ifu) states the following: ¿withdraw the device and microcatheter slowly and carefully as a unit to the guide catheter tip while aspirating through the guide catheter with a syringe.As the device reaches the guide catheter apply vigorous aspiration, withdraw the device and microcatheter into the guide catheter and continue to aspirate until the device reaches the proximal rhv.If withdrawal into the guide catheter is difficult (as may be the case with a large clot burden) then deflate the balloon (if applicable) and withdraw the guide, microcatheter and device together through the introducer sheath.The ifu also cautions 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.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.With the limited information available and without the return of the device for evaluation, it is not possible to determine the root cause of the reported event; however, the event may have been secondary to a combination of multiple factors experienced in the clinical setting.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.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.

Event Description

A report from the field indicated that during a mechanical thrombectomy of a distal internal carotid artery (ica)-middle cerebral artery (mca) (m1 segment) occlusion, the physician found the 6.5mm x 45mm embotrap iii (et307645/unknown lot number) revascularization device was rather stiff and spasm-inducing.He also had trouble retrieving the device from the patient and felt that it was a ¿totally different device from the 5mm¿.The physician further stated that he knows the device can be used in vessels 1.5mm in diameter, but he will not be using it in vessels ¿even twice that size¿.No further information is available.

• Brand Name: EMBOTRAP III 6.5 MM X 45 MM
• Type of Device: 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: 11831825
• MDR Text Key: 250846648
• Report Number: 3011370111-2021-00040
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/27/2021

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 Catalogue Number: ET307645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/17/2021
• 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