MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; CATHETER, THROMBUS RETRIEVER

Model Number ET309537

Device Problem Difficult to Remove (1528)

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

Event Date 06/29/2023

Event Type  Death  

Event Description

The healthcare professional reported that on (b)(6) 2023, during a mechanical thrombectomy procedure targeting a cerebral infarction, the complaint device, a 5mm x 37mm embotrap iii revascularization device (et309537 / lot# unknown) remained in the patient¿s body as a result of the difficulty encountered during the attempt to withdraw the device from the patient¿s vessel.Per the event description, the occluded vessel was not known at the time of the complaint initiation, the system that consisted of a branchor balloon guide catheter (bgc) (asahi-intecc), red 62 reperfusion catheter (penumbra), phenom¿ 21 microcatheter (medtronic), and chikai neurovascular guidewire (asahi intecc) was inserted and crossed the target lesion.The physician attempted to deploy a 3mm x 20mm solitaire¿ revascularization device (medtronic) at first, however, because the microcatheter slipped and it was difficult to treat the occluded lesion / vessel, the 5mm x 37mm embotrap iii revascularization device was selected to use.It was reported that the embotrap iii device was deployed without any issue, it became stuck in the vessel.A continuous flush was reportedly maintained.It was difficult to retrieve the embotrap iii device, or resheath with a microcatheter.¿replacing the microcatheter with phenom 27 or headway 21 and trying to resheath the [embotrap iii device], but it was difficult to retrieve.¿ it was concluded that further attempt at retrieval could cause a device break, therefore, the procedure was completed with ¿sheath/branchor/et309537 remaining in the body.¿ per the event description, ¿regarding the future treatment plan, the choice was whether to remove et309537 by craniotomy or to disconnect et309537 and left in the body.The physician decided et309537 left in the body.¿ post-operative condition of the patient is reported as unknown.The patient was reported to still be in the hospital.On 12-jul-2023, additional information was received.The information requested the addition of the embotrap device lot number 23c022av.The additional information included an updated (and addition) to the description of the mechanical thrombectomy procedure that took place on (b)(6) 2023.The information indicated that the patient had a history of atrial fibrillation.On (b)(6) 2023, when the 3mm x 20mm solitaire¿ stent (medtronic) was inserted into the microcatheter, there was a strong resistance.After it was replaced with a 5mm x 37mm embotrap iii revascularization device (et309537 / 23c022av), the pass history is as follows: first pass: m2 superior trunk.Second pass: m2 inferior trunk.Third pass: m2 superior trunk.A fourth pass was made in the m2 inferior trunk and the embotrap device got stuck in the vessel.The physician decided to leave the entire system set up with the embotrap iii device still inside the patient¿s body.The patient had a second procedure on(b)(6) 2023.During this second procedure, the delivery wire of the embotrap iii device was cut at the proximal part of the wire.Part of the delivery wire and the product was left in the patient¿s body.On (b)(6) 2023, it was reported that the patient had died.The date of death was not provided.It was indicated that the causes of death other than the product was strong tortuosity on the aorta, internal carotid, middle cerebral artery (mca), and the patient¿s advanced age.Via a communication with the japan team, it was clarified that the embotrap iii device left from the first procedure on (b)(6) 2023 with the rest of the ancillary devices was then cut at the femoral artery access during the second procedure that took place on (b)(6) 2023.The physician cut at the proximal part of the wire and left the delivery wire and the embotrap iii device in the patient (as it was from the first procedure).On (b)(6) 2023, response to additional information request was received via email.The additional information indicated that the patient was 87 years old.The first procedure was confirmed to be on (b)(6) 2023.The second procedure was on (b)(6) 2023.This procedure was performed to cut the embotrap device delivery wire left in the patient¿s body and to reduce the remaining parts of the embotrap.During the first procedure, the physician decided to leave the embotrap in the patient; the second procedure, the physician deliberately cut the delivery wire to reduce the remaining parts of the embotrap.The originally reported withdrawal difficulty from the vessel as reported from the first procedure is still applicable.The date of death and information related to additional device issue(s) is being requested from the physician.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, gender, weight, race, and ethnicity were not provided.Section b.2: date of death: the date of death is currently not known.Section e.1: the initial reporter first name, phone and email address are not available / reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of the manufacturing documentation associated with this lot (23c022av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Withdrawal difficulty from vessel is a known potential procedural complication associated with the embotrap iii revascularization device.The instructions for use (ifu) also warns the user to not withdraw the device against significant resistance.There are clinical and procedural factors, including clot burden, vessel characteristics (tortuosity, calcification), device selection, and operator technique, that may have contributed rather than the design or manufacture of the device.With the information available and without the complaint product available to be returned for analysis, the reported issue encountered during the attempt to withdrawal the embotrap iii device from the patient¿s vessel resulting in the device remaining in the patient, cannot be investigated through product analysis and evaluation.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.There was difficulty withdrawing the embotrap iii device from the vessel, which could require the use of increased force.If excessive force were used, this could result in vessel trauma or damage to the basket with the potential for release of the emboli and subsequent ischemia or infarct and/or the need for additional intervention.Per the instructions for use (ifu), there are warning precautions against the use of the embotrap iii device in calcified vessels.Per the event description, the device was left in the patient¿s body, which required additional surgical intervention.Additional information was received on (b)(6) 2023, which indicated that the patient died on (b)(6) 2023.Therefore, this event is reportable to the us fda under 21 cfr 803 with the classification of ¿death.¿ the file will be re-reviewed if additional information is received at a later date.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 05-sep-2023.[additional information]: on 05-sep-2023, additional information was received.The information indicated that anonymized images / angiographs of the procedure are not available.The physician emphasized that the patient¿s vessel was severely tortuous rather than calcification; it was unknown if the physician had previous knowledge of the patient¿s vessel calcification.The target thrombus / clot was not completely removed.The additional information indicated that only the embotrap iii device was left in the patient.The sheath and branchor balloon guide catheter were removed.Per the additional information, it was confirmed that the first attempt to remove the occlusion with the 3mm x 20mm solitaire¿ revascularization device when the microcatheter slipped making it difficult to treat the occlusion was due to the size of the stent retriever (3mm x 20mm).The malfunction of the solitaire was thought due to the size of the stent retriever, ¿so the different size of the embotrap iii was selected.¿ no further information could be obtained.This additional information has been reviewed.Per the embotrap instructions for use (ifu), the use of the device is contraindicated for "excessive vessel tortuosity, as this may prevent device delivery or withdrawal".Nevertheless, this event resulted in a required surgical intervention and the outcome of the patient's death.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: EMBOTRAP III 5 MM X 37 MM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17334741
• MDR Text Key: 319184609
• Report Number: 3011370111-2023-00078
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• 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: 23C022AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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: 3MM X 20MM SOLITAIRE¿ STENT (MEDTRONIC); BRANCHOR BCG (ASAHI-INTECC); CHIKAI NEUROVASCULAR GUIDEWIRE (ASAHI INTECC); PHENOM¿ 21 MICROCATHETER (MEDTRONIC); RED 62 REPERFUSION CATHETER (PENUMBRA)
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 87 YR