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

Model Number ET009533

Device Problem Difficult to Remove (1528)

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

Event Date 08/11/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during the thrombectomy procedure with the target lesion on the internal carotid artery, a trevo trak 21 microcatheter (stryker) crossed the lesion.The a 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown) was deployed and the physician attempted to retract it.It was reported that there was an intense resistance while the embotrap ii device was being retracted because the vessel was calcified due to arteriosclerosis.As a result, the physician stopped retracting the device and resheathed the microcatheter to half of the stent portion of the embotrap ii device before making another attempt to retract.The embotrap ii device was successfully retrieved with no resistance to the tip of the suction.It was reported that it was not clear if continuous flush was maintained.The clot was retrieved and the procedure was completed.There was no report of any patient adverse event or complication.

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The expiration date of the device is not known as the device lot number is not available / not reported.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that during the thrombectomy procedure with the target lesion on the internal carotid artery, a trevo trak 21 microcatheter (stryker) crossed the lesion.The a 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown) was deployed and the physician attempted to retract it.It was reported that there was an intense resistance while the embotrap ii device was being retracted because the vessel was calcified due to arteriosclerosis.As a result, the physician stopped retracting the device and resheathed the microcatheter to half of the stent portion of the embotrap ii device before making another attempt to retract.The embotrap ii device was successfully retrieved with no resistance to the tip of the suction.It was reported that it was not clear if continuous flush was maintained.The clot was retrieved and the procedure was completed.There was no report of any patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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 well-known potential procedural complication associated with the embotrap revascularization device.The ifu also warns the user to not withdraw the device against significant resistance.The most likely cause of the withdrawal difficulty issue encountered during the procedure is related to vessel characteristic which was captured in the complaint.The complaint documented that the intense resistance encountered during the attempt to retract the embotrap ii device was because of vessel calcification due to arteriosclerosis.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.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 13-oct-2021.[additional information]: the healthcare professional reported that during the thrombectomy procedure with the target lesion on the internal carotid artery, a trevo trak 21 microcatheter (stryker) crossed the lesion.The a 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown) was deployed and the physician attempted to retract it.It was reported that there was an intense resistance while the embotrap ii device was being retracted because the vessel was calcified due to arteriosclerosis.As a result, the physician stopped retracting the device and resheathed the microcatheter to half of the stent portion of the embotrap ii device before making another attempt to retract.The embotrap ii device was successfully retrieved with no resistance to the tip of the suction.It was reported that it was not clear if continuous flush was maintained.The clot was retrieved and the procedure was completed.There was no report of any patient adverse event or complication.On 13-oct-2021, additional information was received.The information indicated that the reported intense resistance was confirmed only during the device retraction.The physician thinks that the resistance encountered during the attempt to withdraw the device was the vessel is associated with the patient¿s calcified vessel.There was no issue associated with the concomitant microcatheter that may have contributed to the reported withdrawal issue.The embotrap ii device did not appear damage in anyway.It was reported that the physician stopped retracting the embotrap ii device, the microcatheter was ¿resheathed to half of the stent portion of the embotrap ii and the stent was retracted again.¿ the embotrap ii device was successfully retrieved with no resistance to the tip of the suction.The additional information confirmed that there was no adverse event outcome to the patient as a result of the reported issue; there was no clinically significant delay in the procedure from the reported issue.E.1: the initial reporter phone: (b)(6).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 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: 12530153
• MDR Text Key: 280535764
• Report Number: 3011370111-2021-00111
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREVO TRAK 21 MICROCATHETER (STRYKER)