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 10/08/2022

Event Type  Injury  

Event Description

It was reported from a personal interaction that a patient underwent endovascular mechanical thrombectomy using a 5mm x 37mm embotrap iii revascularization device (et309537/22a134av) for an occlusion at the left middle cerebral artery (mca), m1 segment, and experienced bleeding during the procedure.Details of the procedure: an optimo 9f (tokai medical) balloon guiding catheter was advanced to the left internal carotid artery (ica) and a phenom 21 microcatheter (medtronic) and a micro-guidewire were set on the suction catheter salva (unknown manufacturer).After crossing of the occluded region, the micro-guidewire was removed and the embotrap iii was guided to the inferior trunk.Thrombus was unable to be removed during the first pass using the suction catheter, so the physician did the second pass and embotrap iii was deployed.It was reported that at this time a slight resistance was felt when the complaint device was pulled along with the suction catheter, the blood vessel became straight/stretched, and bleeding occurred.After the bleeding was confirmed by angiography, the affected region was occluded with the balloon guiding catheter for hemostasis.When the hemostasis was confirmed, the device was removed, and the procedure was deemed completed.It was mentioned that because blood flow was immediately blocked and controlled after bleeding with the balloon guiding catheter, the symptoms did not worsen after hemostasis and the patient did not experience any adverse events due to the embotrap iii device.The physician mentioned that a relationship between the event and the device cannot be ruled out although it was considered non-serious (moderate/minimal) taking the pre-existing symptoms of cerebral infarction.The affected blood vessel presented a severe tortuosity.It was stated that continuous flush was maintained and that the embotrap iii device was used as per the ifu.No further information was provided at the time of complaint initiation.

Manufacturer Narrative

Product complaint # (b)(4).The device was discarded; therefore, no further investigation can be performed.A review of the dhr records confirms that there were no issues with the assembly of the lots (sub-assembly and top assembly), all rejects were accounted for during the dhr review.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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).Section b5: additional information received on 15-nov-2022 indicated that the doctor commented that the thrombus was a hard thrombus because the patient suffered from a colon cancer.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: it was reported from a personal interaction that a patient underwent endovascular mechanical thrombectomy using a 5mm x 37mm embotrap iii revascularization device (et309537/22a134av) for an occlusion at the left middle cerebral artery (mca), m1 segment, and experienced bleeding during the procedure.Details of the procedure: an optimo 9f (tokai medical) balloon guiding catheter was advanced to the left internal carotid artery (ica) and a phenom 21 microcatheter (medtronic) and a micro-guidewire were set on the suction catheter salva (unknown manufacturer).After crossing of the occluded region, the micro-guidewire was removed and the embotrap iii was guided to the inferior trunk.Thrombus was unable to be removed during the first pas using the suction catheter, so the physician did the second pass and embotrap iii was deployed.It was reported that at this time a slight resistance was felt when the complaint device was pulled along with the suction catheter, the blood vessel became straight/stretched, and bleeding occurred.After the bleeding was confirmed by angiography, the affected region was occluded with the balloon guiding catheter for hemostasis.When the hemostasis was confirmed, the device was removed, and the procedure was deemed completed.It was mentioned that because blood flow was immediately blocked and controlled after bleeding with the balloon guiding catheter, the symptoms did not worsen after hemostasis and the patient did not experience any adverse events due to the embotrap iii device.The physician mentioned that a relationship between the event and the device cannot be ruled out although it was considered non-serious (moderate/minimal) taking the pre-existing symptoms of cerebral infarction.The affected blood vessel presented a severe tortuosity.It was stated that continuous flush was maintained and that the embotrap iii device was used as per the ifu.Additional information received indicated that the doctor commented that the thrombus was a hard thrombus because the patient suffered from a colon cancer.The device was discarded; therefore, no further investigation can be performed.A review of the dhr records confirms that there were no issues with the assembly of the lots (sub-assembly and top assembly), all rejects were accounted for during the dhr review.Withdrawal difficulty from vessel and hemorrhage secondary to vascular injury are well-known potential complications associated with the use of the embotrap iii in mechanical thrombectomy procedures and are listed in the instructions for use (ifu) as such.The ifu also warns the user to not withdraw the device against significant resistance.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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 pa; 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15699532
• MDR Text Key: 302699735
• Report Number: 3011370111-2022-00107
• 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: 11/30/2022

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 Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 22A134AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 11/11/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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: OPTIMO 9F (TOKAI MEDICAL) BALLOON GUIDING CATHETER; PHENOM 21 MICROCATHETER (MEDTRONIC); SUCTION CATHETER SALVA (UNKNOWN MANUFACTURER); UNSPECIFIED MICRO-GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Sex: Female