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

Catalog Number ET307537

Device Problem Difficult to Remove (1528)

Patient Problems Intracranial Hemorrhage (1891); Vasoconstriction (2126); Perforation of Vessels (2135)

Event Date 02/19/2022

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 and email address are not available / reported.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.A review of the device history records (dhr) confirms that there were no issues with the assembly of the lot 21l112av (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.Withdrawal difficulty from vessel, vasospasm, and subarachnoid hemorrhage (sah) secondary to vessel injury are known potential procedural complications associated with the use of the embotrap and embovac in mechanical thrombectomy.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors including vessel characteristics, clot burden / characteristics, device selection, device interaction, and operator technique that may have contributed rather than the design or manufacture of the devices.Since the alleged withdrawal difficulty from vessel led to vascular injury with sah and vasospasm, the event is considered serious and mdr reportable.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00152 and.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.

Event Description

The healthcare professional reported that during a mechanical thrombectomy of a middle cerebral artery (mca) (m1/m2) occlusion, an 132cm embovac 71 aspiration catheter (ic71132ca / 30582694) and a 5mm x 37mm embotrap iii revascularization device (et307537 / 21l112av) became stuck at the time of withdrawal the first pass was performed without any untoward events and recanalization was achieved at the m1 / m2 junction.Since there was still thrombus at the m2 segment, the treating physician decided to perform another pass with the same system.However, when the treating physician attempted to remove the devices during the second pass, the devices were stuck in the vessel.The embovac was stuck in the proximal m1 segment, and the embotrap was stuck at the m2.When the physician tried to pull back on the system, the concomitant 6f neuron max long sheath (penumbra) which was positioned halfway into the cervical carotid artery began to climb up.The treating physician decided not to use any nimodipine as this was an ¿old¿ patient.The treating physician commented that there may have been tilting of the m1 segment.Since it was impossible to retrieve the system by pulling, he decided to push the system, and was ultimately able to remove the system from the patient.Vasospasm and subarachnoid hemorrhage (sah) were noted on imaging.The distal 2 centimeters (cm) of the embovac was noted to be stretched upon removal.The treating physician does not recall the final/end of procedure tici score, and if any additional thrombectomy attempts were performed.The patient is reportedly doing fine.Concomitant devices included a headway 21 microcatheter (microvention), traxcess guidewire (microvention), and 6f neuron max long sheath (penumbra).The treating physician used a cross-cut valve packaged with the neuron max; the use of the peel away introducer packaged with the embovac was confirmed on both passes.It was reported that both devices are available to be returned for evaluation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that multiple attempts to obtain the product for analysis were unsuccessful.If the product is returned or information is provided at a later date, the complaint file will be updated and the product investigation will be performed and a supplemental 3500a report will be submitted.[conclusion]: the healthcare professional reported that during a mechanical thrombectomy of a middle cerebral artery (mca) (m1/m2) occlusion, an 132cm embovac 71 aspiration catheter (ic71132ca / 30582694) and a 5mm x 37mm embotrap iii revascularization device (et307537 / 21l112av) became stuck at the time of withdrawal the first pass was performed without any untoward events and recanalization was achieved at the m1 / m2 junction.Since there was still thrombus at the m2 segment, the treating physician decided to perform another pass with the same system.However, when the treating physician attempted to remove the devices during the second pass, the devices were stuck in the vessel.The embovac was stuck in the proximal m1 segment, and the embotrap was stuck at the m2.When the physician tried to pull back on the system, the concomitant 6f neuron max long sheath (penumbra) which was positioned halfway into the cervical carotid artery began to climb up.The treating physician decided not to use any nimodipine as this was an ¿old¿ patient.The treating physician commented that there may have been tilting of the m1 segment.Since it was impossible to retrieve the system by pulling, he decided to push the system, and was ultimately able to remove the system from the patient.Vasospasm and subarachnoid hemorrhage (sah) were noted on imaging.The distal 2 centimeters (cm) of the embovac was noted to be stretched upon removal.The treating physician does not recall the final/end of procedure tici score, and if any additional thrombectomy attempts were performed.The patient is reportedly doing fine.Concomitant devices included a headway 21 microcatheter (microvention), traxcess guidewire (microvention), and 6f neuron max long sheath (penumbra).The treating physician used a cross-cut valve packaged with the neuron max; the use of the peel away introducer packaged with the embovac was confirmed on both passes.Multiple attempts to obtain product for analysis were unsuccessful.If product is returned or information provided at a later date, the file will be updated accordingly.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 21l112av (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.The device has not been returned for analysis and therefore, no further investigation can be performed at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Withdrawal difficulty from vessel, vasospasm, and subarachnoid hemorrhage (sah) secondary to vessel injury are known potential procedural complications associated with the use of the embotrap and embovac in mechanical thrombectomy.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors including vessel characteristics, clot burden / characteristics, device selection, device interaction, and operator technique that may have contributed rather than the design or manufacture of the devices.Since the alleged withdrawal difficulty from vessel led to vascular injury with sah and vasospasm, the event is considered serious and mdr reportable.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00152 and 3011370111-2022-00024.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: gabriel alfageme ; 31 technology dr; irvine 92618 ; 949789-868
• MDR Report Key: 13738836
• MDR Text Key: 292056501
• Report Number: 3011370111-2022-00024
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173452
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ET307537
• Device Lot Number: 21L112AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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: 132CM EMBOVAC 71 ASP. CATHETER; HEADWAY® 21 MICROCATHETER (MICROVENTION); NEURON MAX® 088 SHEATH (PENUMBRA); TRAXCESS® GUIDEWIRE (MICROVENTION)
• Patient Outcome(s): Life Threatening