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 Problem Intracranial Hemorrhage (1891)

Event Date 07/24/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address was not available / reported.[conclusion]: the healthcare professional reported that during a thrombectomy procedure targeting a cerebral infarction with the occlusion located at the distal m1 (m1d) of the middle cerebral artery (mca), three passes were made with a solitaire¿ stent retriever (medtronic), but some thrombus was left behind.No aspiration catheter was used.There was no resistance felt when the solitaire was used, but because the thrombus still remained, a 5mm x 37mm embotrap iii revascularization device (et309537 / 21m129av) was used.The embotrap iii device was inserted into the patient and delivered to the target lesion.An attempt to deploy was made, however, there was resistance felt when the embotrap iii was being retracted.The embotrap iii device was removed by resheathing.Bleeding was confirmed during contrast imaging at the time of removal.The procedure was completed with coil embolization at the point of the bleed.The physician commented, ¿i don¿t know if it was due to the use of the products or the patient¿s condition.Thrombus recovery has about a 10% bleeding risk, so isn¿t it natural?¿ the patient was hospitalized while under observation.It was reported that if the prognosis was poor, treatment will be shifted to craniotomy or endovascular treatment, but at present, the physician has been considering rehabilitation.The event was considered non-serious (moderate / minimal) because coil was used for bleeding only ¿as a safety measure.¿ the patient has been recovering from the onset of cerebral infarction.The risk of bleeding due to cerebral infarction is generally about 10%, so this may be unavoidable.The physician commented, ¿the prognosis has been better than that before the procedure because the patient was transported by cerebral infarction.¿ a trak microcatheter (stryker) was used; continuous flush was maintained.On 05-aug-2022, additional information was received.The information indicated that it was the mechanical thrombectomy was targeting an occlusion at the distal end m1 segment (m1d) of the middle cerebral artery (mca).The reported bleeding was treated by coil(s).However, the physician stated that the treatment ¿was just in case.If the prognosis was poor, treatment will be shifted to craniotomy or endovascular treatment, but at present, the physician has been considering rehabilitation.¿ related to the current condition of the patient, the information indicated that the prognosis has been better than that of before the procedure, because the patient was ¿transported by cerebral infarction and recanalization was obtained.¿ excessive force was not applied to the device.The device was removed from the patient without the need for additional intervention; there was no device fragment that remained in the patient.Continuous flush was maintained during the procedure.The procedure was completed with coil embolization.The patient is continued to be monitored via follow-up.The device was inspected prior to use, no damage was reported.It was prepped in accordance with the instructions for use (ifu).There was no packaging issue; the labeling was correct.The inner pouch was securely sealed and there was no evidence of tampering.Based on complaint information, the device is not available to be returned for analysis.A review of the device history records (dhr) confirms that there were no issues with the assembly of the lot 21m129av (sub and top assembly).There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.Intracranial hemorrhage is a known complication associated with the use of the embotrap device and is mentioned in the instructions for use (ifu) as such.Difficulty withdrawing the device 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.Per the information provided, bleeding was confirmed on imaging when the embotrap device was removed, which resulted in the use of coils to treat the bleed.Therefore, this event meets mdr reporting criteria as a ¿serious injury.¿ with the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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 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.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.

Event Description

The healthcare professional reported that during a thrombectomy procedure targeting a cerebral infarction with the occlusion located at the distal m1 (m1d) of the middle cerebral artery (mca), three passes were made with a solitaire¿ stent retriever (medtronic), but some thrombus was left behind.No aspiration catheter was used.There was no resistance felt when the solitaire was used, but because the thrombus still remained, a 5mm x 37mm embotrap iii revascularization device (et309537 / 21m129av) was used.The embotrap iii device was inserted into the patient and delivered to the target lesion.An attempt to deploy was made, however, there was resistance felt when the embotrap iii was being retracted.The embotrap iii device was removed by resheathing.Bleeding was confirmed during contrast imaging at the time of removal.The procedure was completed with coil embolization at the point of the bleed.The physician commented, ¿i don¿t know if it was due to the use of the products or the patient¿s condition.Thrombus recovery has about a 10% bleeding risk, so isn¿t it natural?¿ the patient was hospitalized while under observation.It was reported that if the prognosis was poor, treatment will be shifted to craniotomy or endovascular treatment, but at present, the physician has been considering rehabilitation.The event was considered non-serious (moderate / minimal) because coil was used for bleeding only ¿as a safety measure.¿ the patient has been recovering from the onset of cerebral infarction.The risk of bleeding due to cerebral infarction is generally about 10%, so this may be unavoidable.The physician commented, ¿the prognosis has been better than that before the procedure because the patient was transported by cerebral infarction.¿ a trak microcatheter (stryker) was used; continuous flush was maintained.On 05-aug-2022, additional information was received.The information indicated that it was the mechanical thrombectomy was targeting an occlusion at the distal end m1 segment (m1d) of the middle cerebral artery (mca).The reported bleeding was treated by coil(s).However, the physician stated that the treatment ¿was just in case.If the prognosis was poor, treatment will be shifted to craniotomy or endovascular treatment, but at present, the physician has been considering rehabilitation.¿ related to the current condition of the patient, the information indicated that the prognosis has been better than that of before the procedure, because the patient was ¿transported by cerebral infarction and recanalization was obtained.¿ excessive force was not applied to the device.The device was removed from the patient without the need for additional intervention; there was no device fragment that remained in the patient.Continuous flush was maintained during the procedure.The procedure was completed with coil embolization.The patient is continued to be monitored via follow-up.The device was inspected prior to use, no damage was reported.It was prepped in accordance with the instructions for use (ifu).There was no packaging issue; the labeling was correct.The inner pouch was securely sealed and there was no evidence of tampering.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 29-sep-2022.[additional information]: on 29-sep-2022, additional information was received.The information indicated that anonymized images / angiographs of the procedure are not available.There was no report of any vessel trauma / injury that resulted in the bleed.The physician reportedly did not know if it was due to the use of the products or the patient¿s condition that may have caused or contributed to the reported bleed.Per the physician, ¿thrombus recovery has about a 10% bleeding risk, so isn¿t it natural?¿ the bleeding was most probably successfully treated with the coils since the procedure was completed.The information confirmed that a continuous flush was maintained.The patient is reportedly doing better than pre-procedure.Additional follow-up on the patient¿s condition was unsuccessful.There was no report of any delay in the procedure due to the reported event.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: 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: 15219767
• MDR Text Key: 297862058
• Report Number: 3011370111-2022-00074
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• 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: 21M129AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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: TRAK MICROCATHETER (STRYKER).
• Patient Outcome(s): Required Intervention