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

Catalog Number ET009533

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682)

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

Event Type  Injury  

Event Description

It was reported by a healthcare professional that during a mechanical thrombectomy of a middle cerebral artery (mca) occlusion with associated acute ischemic stroke, there was resistance encountered as the 5mm x 33mm embotrap ii revascularization device (et009533/21e030av) was being retracted under mechanical pump aspiration.It was stated that the target thrombus was hard, and ¿it was pulled in like passing through¿.Only a portion of the thrombus was removed.At the same time, the 132cm embovac 71 aspiration catheter (ic71132ca/unknown lot number) was noted to be stretched and with a hole.Next, the embotrap ii was used twice ¿by a simple stent¿ but thrombus was not removed.The branch of the m2 was then changed, and a react 68 aspiration catheter (medtronic) was advanced to the m1 via conventional technique.The embotrap and react 68 were used twice by continuous aspiration prior to intracranial vascular embolectomy (captive) technique, but it was impossible to remove the thrombus.Thus, the treating physician decided to complete the procedure without obtaining recanalization to avoid risks to patient.After the procedure, a small amount of subarachnoid hemorrhage (sah) was noted at the distal m1.However, it was reported that the sah did not lead to a major hemorrhage ¿probably because there was no recanalization¿ and the sequelae was mainly associated with the baseline cerebral infarction.There was a continuous flush maintained.Concomitant devices included a trevo trak 21 microcatheter (stryker) and a 9f optimo balloon guide catheter (tokai medical).The trevo trak 21 microcatheter was advanced past the target lesion, and the embotrap ii was deployed at the m2.The embovac was guided via rexas technique and the embotrap was ¿pulled while sucking the pump¿.However, the thrombus was hard and there was a resistance felt on the way.No further information was provided at the time of complaint initiation.

Manufacturer Narrative

Product complaint # (b)(4).The initial reporter phone and email address are not available / reported.The device was discarded; therefore, no further investigation can be performed.A device history review (dhr) associated with lot 21e030av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00539.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received on 04-nov-2021 indicating that the lot number of the embovac catheter was 30550157.The target occlusion was located around the m1 segment of the mca.Rexas technique is ¿rapid exchange aspiration after stent deployment¿.Medical and/or surgical intervention was not required for the sah.Anonymized procedural films/images are not available for review.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) occlusion with associated acute ischemic stroke, there was resistance encountered as the 5mm x 33mm embotrap ii revascularization device (et009533/21e030av) was being retracted under mechanical pump aspiration.It was stated that the target thrombus was hard, and ¿it was pulled in like passing through¿.Only a portion of the thrombus was removed.At the same time, the 132cm embovac 71 aspiration catheter (ic71132ca/unknown lot number) was noted to be stretched and with a hole.Next, the embotrap ii was used twice ¿by a simple stent¿ but thrombus was not removed.The branch of the m2 was then changed, and a react 68 aspiration catheter (medtronic) was advanced to the m1 via conventional technique.The embotrap and react 68 were used twice by continuous aspiration prior to intracranial vascular embolectomy (captive) technique, but it was impossible to remove the thrombus.Thus, the treating physician decided to complete the procedure without obtaining recanalization to avoid risks to patient.After the procedure, a small amount of subarachnoid hemorrhage (sah) was noted at the distal m1.However, it was reported that the sah did not lead to a major hemorrhage ¿probably because there was no recanalization¿ and the sequalae was mainly associated with the baseline cerebral infarction.There was a continuous flush maintained.Concomitant devices included a trevo trak 21 microcatheter (stryker) and a 9f optimo balloon guide catheter (tokai medical).The trevo trak 21 microcatheter was advanced past the target lesion, and the embotrap ii was deployed at the m2.The embovac was guided via rexas technique and the embotrap was ¿pulled while sucking the pump¿.However, the thrombus was hard and there was a resistance felt on the way.Additional information received on 04-nov-2021 indicating that the lot number of the embovac catheter was 30550157.The target occlusion was located around the m1 segment of the mca.Rexas technique is ¿rapid exchange aspiration after stent deployment¿.Medical and/or surgical intervention was not required for the sah.Anonymized procedural films/images are not available for review.The device was not available for analysis.A device history review associated with lot 21e030av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Withdrawal difficulty from vessel, hemorrhage secondary to vascular injury, and device ineffective with treatment failure 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 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.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; 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: 12700754
• MDR Text Key: 283966083
• Report Number: 3011370111-2021-00130
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ET009533
• Device Lot Number: 21E030AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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: 132CM EMBOVAC 71 ASP. CATHETER.; 9F OPTIMO BALLOON GUIDE CATHETER (TOKAI MEDICAL).; REACT 68 ASPIRATION CATHETER (MEDTRONIC).; TREVO TRAK 21 MICROCATHETER (STRYKER).