MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Catalog Number ET307645

Device Problems Difficult to Remove (1528); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity 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 Description

It was reported by a healthcare professional (hcp) that a patient underwent a mechanical thrombectomy at the m1 segment of the middle cerebral artery and carotid artery using a 6.5mm x 45mm embotrap iii revascularization device (et307645, lot unknown), due to an ischemic stroke.Per the event description, the first attempt at clot removal was done using a jet 7 (penumbra) aspiration catheter, which was advanced through the vessel using a prowler select microcatheter.Following this first step, the healthcare provider noticed kinking in the aspiration catheter followed by stretching of the catheter itself until the distal part broke off (approximately 20 cm).The hcp then used a snare device to retrieve the catheter material.A second attempt at clot removal was performed using a new jet 7 aspiration catheter and a new prowler select microcatheter, but no reperfusion was obtained.The third attempt at clot removal was performed using the embotrap device in combination with the jet 7 aspiration catheter.During the retrieval phase of the stent retriever, the hcp felt a lot of resistance but continued with the retraction.He then noticed that the embotrap device had detached and had remained in place.The hcp then proceeded to use a new snare to try and recapture the stent but was unsuccessful.The fourth attempt at clot removal was made, but it was unsuccessful.The procedure ended without having obtained recanalization of the vessel and the occlusion remained as it was at the start of the procedure.The patient had no consequences or further complications.It¿s unknown if surgery was delayed due to the event.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information was received on 15-jun-2022 indicating that the event date was 23-may-2022.The lot number is not available for the prowler select microcatheter.There were no alleged product malfunctions with the first prowler select used.As described the embotrap stent was ¿¿detached¿¿ and no additional intervention has been planned.During advancement, the device did not torque or rotate.The length of the thrombus was unknown.There was no difficulty advancing either of the two prowler select microcatheters through the thrombus.The event did not result in thromboembolism and there was no vessel damage due to the event.It¿s unknown how long the procedure was delayed and whether or not it was significant.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #(b)(4).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 (hcp) that a patient underwent a mechanical thrombectomy at the m1 segment of the middle cerebral artery and carotid artery using a 6.5mm x 45mm embotrap iii revascularization device (et307645), due to an ischemic stroke.Per the event description, the first attempt at clot removal was done using a jet 7 (penumbra) aspiration catheter, which was advanced through the vessel using a prowler select microcatheter.Following this first step, the healthcare provider noticed kinking in the aspiration catheter followed by stretching of the catheter itself until the distal part broke off (approximately 20 cm).The hcp then used a snare device to retrieve the catheter material.A second attempt at clot removal was performed using a new jet 7 aspiration catheter and a new prowler select microcatheter, but no reperfusion was obtained.The third attempt at clot removal was performed using the embotrap device in combination with the jet 7 aspiration catheter.During the retrieval phase of the stent retriever, the hcp felt a lot of resistance but continued with the retraction.He then noticed that the embotrap device had detached and had remained in place.The hcp then proceeded to use a new snare to try and recapture the stent but was unsuccessful.The fourth attempt at clot removal was made, but it was unsuccessful.The procedure ended without having obtained recanalization of the vessel and the occlusion remained as it was at the start of the procedure.The patient had no consequences or further complications.It¿s unknown if surgery was delayed due to the event.Additional information received indicated that the event date was 23-may-2022.The lot number is not available for the prowler select microcatheter.There were no alleged product malfunctions with the first prowler select used.As described the embotrap stent was ¿¿detached¿¿ and no additional intervention has been planned.During advancement, the device did not torque or rotated.The length of the thrombus was unknown.There was no difficulty advancing either of the two prowler select microcatheters through the thrombus.The event did not result in thromboembolism and there was no vessel damage due to the event.It¿s unknown how long the procedure was delayed and whether or not it was significant.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 the vessel is a potential complication 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.A device detached from the wire-in patient is considered an mdr reportable malfunction since the separation of the device could result in vessel damage, embolization, ischemia or infarct, and/or the need for additional intervention.Furthermore, the relationship of the embotrap iii to the reported event cannot be excluded.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 6.5 MM X 45 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: 14619240
• MDR Text Key: 293449558
• Report Number: 3011370111-2022-00050
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 08/17/2022
• 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
• Treatment: JET 7 (PENUMBRA) ASPIRATION CATHETER; TWO PROWLER SELECT MICROCATHETER
• Patient Outcome(s): Required Intervention