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 Intracranial Hemorrhage (1891); Perforation of Vessels (2135)

Event Type  Injury  

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.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was discarded; therefore, no additional investigation can be performed.A review of the manufacturing documentation associated with lot number 19d099av presented no issues during the manufacturing or inspection process that can be related to the reported event.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 Description

A report from the field indicated that a (b)(6) year female patient underwent an endovascular mechanical thrombectomy using a 5x33 embotrap ii (et009533/ 19d099av) device for an occlusion at the m1p (m1 proximal) segment of the middle cerebral artery (mca) and experienced a hemorrhagic event and resistance.Access to the target lesion was made by a 9f sheath, cat 7 (stryker) aspiration catheter, marksman (medtronic) microcatheter, and the embotrap ii.During the first pass made, the embotrap ii was deployed and attempted to be retracted but resistance was felt and the stent was not able to move.The physician attempted to advance the marksman microcatheter over the embotrap but it was not able to move distally.Thus, he removed the marksman microcatheter and switched to a tactics microcatheter but the situation remained the same.Ultimately, the physician switched to a prowler select plus microcatheter and was able to re-sheath half the stent to aid with withdrawal.The stent was replaced with a solitaire (medtronic) thrombectomy device and an attempt was made to re-access the target lesion.When the physician took a picture before using the solitaire, an extravasation was revealed however he finished the procedure as it was.It is unknown whether the cause of the extravasation is related to the embotrap ii or the microcatheter(s).There were also findings of an ¿atbi¿ (presuming a traumatic brain injury (tbi)).It was reported that it is undeniable that the blood vessels may have become accordion-like because the microcatheter was manipulated back and forth before deploying the stent.After the procedure, the patient was transferred with a mtici of 1, nihss of 12, and mrs of 5.Additional information received from the sales rep indicated that m1p means m1 proximal segment of the mca.There was no reported relevant anatomical information regarding vessel characteristics.No excessive force was applied to the embotrap device.No further information was provided regarding clarification of atbi and if the extravasation required further medical treatment.

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: a report from the field indicated that a 90 year female patient underwent an endovascular mechanical thrombectomy using a 5x33 embotrap ii (et009533/19d099av) device for an occlusion at the m1p (m1 proximal) segment of the middle cerebral artery (mca) and experienced a hemorrhagic event and resistance.Access to the target lesion was made by a 9f sheath, cat 7 (stryker) aspiration catheter, marksman (medtronic) microcatheter, and the embotrap ii.During the first pass made, the embotrap ii was deployed and attempted to be retracted but resistance was felt and the stent was not able to move.The physician attempted to advance the marksman microcatheter over the embotrap but it was not able to move distally.Thus, he removed the marksman microcatheter and switched to a tactics microcatheter but the situation remained the same.Ultimately, the physician switched to a prowler select plus microcatheter and was able to re-sheath half the stent to aid with withdrawal.The stent was replaced with a solitaire (medtronic) thrombectomy device and an attempt was made to re-access the target lesion.When the physician took a picture before using the solitaire, an extravasation was revealed however he finished the procedure as it was.It is unknown whether the cause of the extravasation is related to the embotrap ii or the microcatheter(s).There were also findings of an ¿atbi¿ (presuming a traumatic brain injury (tbi)).It was reported that it is undeniable that the blood vessels may have become accordion-like because the microcatheter was manipulated back and forth before deploying the stent.After the procedure, the patient was transferred with a mtici of 1, nihss of 12, and mrs of 5.Additional information received from the sales rep indicated that m1p means m1 proximal segment of the mca.There was no reported relevant anatomical information regarding vessel characteristics.No excessive force was applied to the embotrap device.No further information was provided regarding clarification of atbi and if the extravasation required further medical treatment.The device was discarded; therefore, no additional investigation can be performed.A review of the manufacturing documentation associated with lot number 19d099av presented no issues during the manufacturing or inspection process that can be related to the reported event.Vessel injury and intracranial hemorrhage are known potential complications associated with the embotrap device and procedures involving device manipulation within the intracranial vasculature.The root cause of the withdrawal difficulty and hemorrhage cannot be conclusively confirmed without procedural images to review; however, procedural factors or the patient¿s vascular anatomy may have contributed to the event.The ifu warns the user to not withdraw the embotrap device against significant resistance, and to assess the cause of the resistance using fluoroscopy and if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.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.
• 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: 11112009
• MDR Text Key: 231953542
• Report Number: 3011370111-2021-00002
• 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
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2022
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 19D099AV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9F SHEATH, CAT 7 (STRYKER) ASPIRATION CATHETER; MARKSMAN (MEDTRONIC) MICROCATHETER; PROWLER SELECT PLUS MICROCATHETER; SOLITAIRE (MEDTRONIC) THROMBECTOMY DEVICE; TACTICS MICROCATHETER
• Patient Age: 90 YR