MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309537

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported, from a personal interaction, that a patient underwent endovascular mechanical thrombectomy using a 5mm x 37mm embotrap iii (et309537/22f168av) for an occlusion at the middle cerebral artery (mca), m1 segment.Per the event description, rough thrombus was removed on the 1st and 3rd pass with the embotrap iii device, but recanalization was not obtained.It was stated that the procedure was challenging and that the embotrap iii device was trapped due to the severe tortuosity at the m1 segment of the mca.Subsequently, a tron fx 4x40 stent retriever (jimro co., ltd., gunma, japan) was used but recanalization was not obtained.Concomitant devices used during the procedure include two guidewires chikai 14 200 cm, (asahi intecc), two guiding catheters optimo 8 frx 90 cm (tokai medical), two trevo trak 21 microcatheters (stryker), a gateway 9×2mm device and two sofia flow 6 fr 125 cm intermediate catheters (microvention).The current status of the patient is unknown.A continuous flush was performed.No further information was provided at the time of complaint initiation.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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-assemblies 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).Updated sections on this medwatch: b4, b5, e1, e2, e3 g3, g6, h2 and h10.Section b5: additional information indicated that the event did not result in thromboembolism.The physician stated that the clot retrieved had a firm and dried consistency.It was further stated that device withdrawal was performed as per the ifu, without any vessel damage and that the device expand as expected.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 (et309537/22f168av) for an occlusion at the middle cerebral artery (mca), m1 segment.Per the event description, rough thrombus was removed on the 1st and 3rd pass with the embotrap iii device, but recanalization was not obtained.It was stated that the procedure was challenging and that the embotrap iii device was trapped due to the severe tortuosity at the m1 segment of the mca.Subsequently, a tron fx 4x40 stent retriever (jimro co., ltd., gunma, japan) was used but recanalization was not obtained.Concomitant devices used during the procedure include two guidewires chikai 14 200 cm, (asahi intecc), two guiding catheters optimo 8 frx 90 cm (tokai medical), two trevo trak 21 microcatheters (stryker), a gateway 9×2mm device and two sofia flow 6 fr 125 cm intermediate catheters (microvention).The current status of the patient is unknown.A continuous flush was performed.No further information was provided at the time of complaint initiation.Additional information received on 17-nov-2022.Summary of additional information provided: the event did not result in thromboembolism.The physician stated that the clot retrieved had a firm and dried consistency.It was further stated that device withdrawal was performed as per the ifu, without any vessel damage and that the device expand as expected.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-assemblies and top assembly), all rejects were accounted for during the dhr review.Withdrawal difficulty is a known potential procedural complication associated with the embotrap device and is listed in the instructions for use (ifu) as such.The ifu also warns the user to not withdraw the device against significant resistance.The root cause of the event cannot be conclusively determined based on the limited information available for review; however, clinical and procedural factors including clot burden, vessel characteristics, tortuosity, device selection, and operator technique are all factors that may have contributed.The ifu also lists excessive vessel tortuosity as a contraindication for device usage.There is no indication of any manufacturing or design issues related to the event.Withdrawal difficulty from vessel meets mdr reporting criteria as a 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.Treatment failure is a known potential outcome associated with endovascular mechanical thrombectomy.The root cause of the inability to achieve a mtici score of =2b with three embotrap passes cannot be conclusively determined.However, there are clinical and procedural factors, including clot burden/characteristics, anatomical challenges, and operator technique, that may have contributed.Device ineffective with treatment failure does not meet mdr reporting criteria since the outcome (mtici score =2a) is not related to a malfunction of the device but rather to the natural progression of the underlying disease process.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 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15673667
• MDR Text Key: 307117353
• Report Number: 3011370111-2022-00105
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 22F168AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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: GATEWAY 9×2MM DEVICE; TRON FX 4X40 STENT RETRIEVER; TWO GUIDEWIRES CHIKAI 14 200 CM, (ASAHI INTECC),; TWO GUIDING CATHETERS OPTIMO 8 FRX 90 CM; TWO SOFIA FLOW 6 FR 125 CM INTERMEDIATE CATHETERS; TWO TREVO TRAK 21 MICROCATHETERS (STRYKER)