MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Model Number ET009533

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

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

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The lot number was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Type of reportable event: since it appears that the procedure had to be aborted prior to the patient receiving intended/adequate treatment (i.E., tici score of 1), the event meets mdr reporting criteria as a ¿serious injury¿.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

A report from the field indicated that during a mechanical thrombectomy of an internal carotid artery (ica) occlusion, a 5mm x 33mm embotrap ii (et009533/unknown lot number) revascularization device was used in conjunction with a cat 7 (stryker) aspiration catheter, but resistance was felt at the time of retrieval, and the device could not be withdrawn.A phenom 27 (medtronic) microcatheter which had previously been removed was returned to its original position and used to aid in device retrieval.The microcatheter was advanced over the embotrap to partially resheath, despite the reported resistance.It was reported that the procedure was completed with tici score of 1 ¿in poor condition¿.The physician commented that the outer segment of the embotrap ii might have been caught in the ¿atbi¿, but he could not make a definite judgment.The direct aspiration first pass technique (adapt) technique was performed initially with the cat 7 aspiration catheter to remove the soft red thrombus, but the vessel occlusion was not reopened.Therefore, the physician opted to perform the combine technique with the embotrap ii stent retriever and cat 7 aspiration catheter.Additional information received on 25 mar 2021 indicated that the device lot number has been requested.¿atbi¿ is a medical abbreviation that means atherothrombotic brain infarction.The device was reportedly used and prepped as per the instructions for use (ifu).It is not known whether the intended procedure was aborted due to the difficulty encountered with the embotrap device and if any further follow-up interventions/procedures are planned.No further details could be obtained.

Manufacturer Narrative

Product complaint #(b)(4).Section e1: initial reporter phone: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a report from the field indicated that during a mechanical thrombectomy of an internal carotid artery (ica) occlusion, a 5mm x 33mm embotrap ii (et009533/unknown lot number) revascularization device was used in conjunction with a cat 7 (stryker) aspiration catheter, but resistance was felt at the time of retrieval, and the device could not be withdrawn.A phenom 27 (medtronic) microcatheter which had previously been removed was returned to its original position and used to aid in device retrieval.The microcatheter was advanced over the embotrap to partially resheath, despite the reported resistance.It was reported that the procedure was completed with tici score of 1 ¿in poor condition¿.The physician commented that the outer segment of the embotrap ii might have been caught in the ¿atbi¿, but he could not make a definite judgment.The direct aspiration first pass technique (adapt) technique was performed initially with the cat 7 aspiration catheter to remove the soft red thrombus, but the vessel occlusion was not reopened.Therefore, the physician opted to perform the combine technique with the embotrap ii stent retriever and cat 7 aspiration catheter.Additional information received indicated that ¿atbi¿ is a medical abbreviation that means atherothrombotic brain infarction.The device was reportedly used and prepped as per the instructions for use (ifu).It is not known whether the intended procedure was aborted due to the difficulty encountered with the embotrap device and if any further follow-up interventions/procedures are planned.No further details could be obtained.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Withdrawal difficulty is a known potential procedural complication associated with the embotrap ii revascularization device.The embotrap ifu warns the user to never withdraw the device against significant resistance.Assess the cause of resistance using fluoroscopy and if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.With the information provided, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors, including vessel characteristics, tortuosity, clot burden/characteristics, device interaction, device selection, and operator technique, that may have contributed to the event rather than the design or manufacture of the device.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 to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt; business park; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 11614329
• MDR Text Key: 260761216
• Report Number: 3011370111-2021-00036
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAT 7 (STRYKER) ASPIRATION CATHETER.; PHENOM 27 (MEDTRONIC) MICROCATHETER.