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

Model Number ET309537

Device Problem Difficult to Remove (1528)

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

Event Date 05/21/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Lot: the lot number was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Device evaluated by mfr - the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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 Description

It was reported from a personal interaction that a (b)(6) patient underwent a mechanical thrombectomy at the m2 segment of the middle cerebral artery using a 5mm x 37mm embotrap iii revascularization device (et309537, lot unknown) and experienced bleeding after the procedure.The first two passes were done using the embotrap device, then a solitaire revascularization device (medtronic) and a trevo stentriever (stryker neurovascular) were used.Per the event description, the patient¿s blood vessel had a flexion enough to cause kinking in the guiding.The embotrap device was not used at the end of the procedure since the suction catheter was ¿like an accordion¿.An attempt was made to access the m2 lesion with the embotrap, but when withdrawing the device there was strong resistance, and it was not possible to withdraw the device.Since a torque was not attached, the trak microcatheter came off while attempting to withdraw the device and it was decided to pull the device without the microcatheter.The resistance was so strong that the blood vessel became elongated, but with gradually and continuously force the device was removed and a hard white thrombus was also removed, which resulted in recanalization.As a result of the difficulties removing the embotrap device, there was a little bleeding after the procedure, but the patient did not experience any adverse events due to the embotrap.A continuous flush was done.The concomitant devices used were an optimo balloon catheter (tokai pharmaceuticals), a chikai guidewire (asahi intecc), and a trak microcatheter (stryker neurovascular).

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information was received on 20-jun-2022 indicating that there were no symptoms due to bleeding.There was no medical intervention such as drug administration or extension of hospitalization.The patient has already been discharged from the hospital.The physician's comment: it occurs with any stent; therefore, it doesn't mean that the issue occurred because of the embotrap.Additional information was again received on 29-jun-2022 indicating that the physician commented that this issue can occur with any device.No further information is available on the patient¿s baseline neurological condition or the pre and post-procedure tici value.There were no surgical interventions performed to treat the event and the event did not lead to permanent deficits.The clot¿s consistency was firm and white.The withdrawal was performed per the ifu.There is no further information available regarding the patient¿s demographic information.There were no malfunctions reported for the concomitant devices.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: it was reported from a personal interaction that a (b)(6) patient underwent a mechanical thrombectomy at the m2 segment of the middle cerebral artery using a 5mm x 37mm embotrap iii revascularization device (et309537) and experienced bleeding after the procedure.The first two passes were done using the embotrap device, then a solitaire revascularization device (medtronic) and a trevo stentriever (stryker neurovascular) were used.Per the event description, the patient¿s blood vessel had a flexion enough to cause kinking in the guiding.The embotrap device was not used at the end of the procedure since the suction catheter was ¿like an accordion¿.An attempt was made to access the m2 lesion with the embotrap, but when withdrawing the device there was strong resistance, and it was not possible to withdraw the device.Since a torque was not attached, the trak microcatheter came off while attempting to withdraw the device and it was decided to pull the device without the microcatheter.The resistance was so strong that the blood vessel became elongated, but with gradually and continuously force the device was removed and a hard white thrombus was also removed, which resulted in recanalization.As a result of the difficulties removing the embotrap device, there was a little bleeding after the procedure, but the patient did not experience any adverse events due to the embotrap.A continuous flush was done.The concomitant devices used were an optimo balloon catheter (tokai pharmaceuticals), a chikai guidewire (asahi intecc), and a trak microcatheter (stryker neurovascular).Additional information was received indicating that there were no symptoms due to bleeding.There was no medical intervention such as drug administration or extension of hospitalization.The patient has already been discharged from the hospital.The physician's comment: it occurs with any stent; therefore, it doesn't mean that the issue occurred because of the embotrap.Further information received indicated that the physician commented that this issue can occur with any device.No further information is available on the patient¿s baseline neurological condition or the pre and post-procedure tici value.There were no surgical interventions performed to treat the event and the event did not lead to permanent deficits.The clot¿s consistency was firm and white.The withdrawal was performed per the ifu.There is no further information available regarding the patient¿s demographic information.There were no malfunctions reported for the concomitant devices.The device was received for analysis.On visual inspection, under magnification, all markers were intact (3 distal markers, 16 body markers ¿ 4 per body section and 2 proximal markers) and undamaged on the returned embotrap device.Visual inspection on the distal coil and the laser welded parts of the distal coil, under magnification, didn¿t indicate any damage or deformation.Visual inspection on the proximal coil, under magnification, indicated coil offsets.All adhesive bonds were noted to be properly formed and intact.Visual inspection on the proximal portion of the inner channel and the outer cage, under magnification, indicated minor deformation which appears to be the origin of the misalignment between the inner channel and outer cage, visible through the inner channel appearing off-centre relative to the outer cage.This slight deformation /coil offset noted on the proximal coil immediately proximal to the proximal joint bond and mis-aligned inner channel suggests a compressing force was applied to attempt to advance the device against resistance.The returned embotrap was successfully passed through a 0.0195¿ tube, confirming that the profile conformed to the specification for compatibility with 0.021¿ microcatheters.Functional testing of the returned embotrap device with a sample prowler select plus (microcatheter).The test demonstrated that the returned embotrap device successfully passed through the sample prowler select plus without any noted resistance and the stent like assembly of the embotrap was deployed.Also, no resistance was noted during the withdrawal from the microcatheter.Visual inspection of the embotrap device post testing did not indicate any additional damage or deformation.This result suggests that the deformation noted on the device did not impact device performance.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.From the visual inspection and the functional testing of the returned embotrap, it was confirmed that the device functioned as intended.No evidence of device defect which can cause the withdrawal resistance was confirmed.Withdrawal difficulty from the vessel and cerebral hemorrhage secondary to vascular injury are well-known potential complications associated with the use of the embotrap iii in mechanical thrombectomy procedures.There are vessel characteristics, clot burden/characteristics, device selection, operator technique, device interaction, and mechanical manipulation of devices within the artery that may have contributed to the event.There is no indication of a device design or manufacturing issue.Withdrawal difficulty from the vessel is considered an mdr reportable malfunction as it could result in vessel trauma, vessel spasm, damage to the basket with the potential for release of emboli, and subsequent ischemia or infarct and/or the need for additional intervention.Therefore, this event is considered serious and mdr reportable.The complaint will be reassessed if additional information becomes available.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 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: 14635045
• MDR Text Key: 293624211
• Report Number: 3011370111-2022-00054
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 22C041AV
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: CHIKAI GUIDEWIRE (ASAHI INTECC); OPTIMO BALLOON CATHETER (TOKAI PHARMACEUTICALS); SOLITAIRE REVASCULARIZATION DEVICE (MEDTRONIC); TRAK MICROCATHETER (STRYKER NEUROVASCULAR); TREVO STENTRIEVER (STRYKER NEUROVASCULAR)
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR