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 01/29/2021

Event Type  malfunction  

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 manufacturing documentation associated with lot number 20d088av presented no issues during the manufacturing or inspection process that can be related to the reported event.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

A report from the field indicated that an (b)(6)-year-old female patient presented with paralytic symptoms and subsequently underwent a mechanical thrombectomy of a m2 occlusion using a 5x33 embotrap ii (et009533/ 20d088av) device on 29-jan-2021.A guidewire was directed up towards the m2 and a marksman catheter was delivered to the region where the embotrap ii was intended to be deployed.The embotrap was deployed but it was not able to be retracted.Thus, the physician attempted to retract the device by advancing the microcatheter over the device however the microcatheter was not able to advance further from the thrombus.¿the blood vessel stretched¿ but the embotrap was not able to be retracted.As a result, the microcatheter was removed from the patient and a 3 max thrombectomy catheter was used to remove the embotrap.After that, reopening was confirmed by angiography.There was minimal occlusion in the branch but the procedure completed without any further treatment because they were peripheral.There were no symptoms such as bleeding and dissection reported.Per the physician, potential factors that might have contributed to the withdrawal difficulty was that the embotrap might have stuck on plaque or the thrombus was hard.He is unsure because the exact time of occurrence of the event is unknown.

Manufacturer Narrative

Product complaint # (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 an 82-year-old female patient presented with paralytic symptoms and subsequently underwent a mechanical thrombectomy of a m2 occlusion using a 5x33 embotrap ii (et009533/ 20d088av) device on (b)(6) 2021.A guidewire was directed up towards the m2 and a marksman catheter was delivered to the region where the embotrap ii was intended to be deployed.The embotrap was deployed but it was not able to be retracted.Thus, the physician attempted to retract the device by advancing the microcatheter over the device however the microcatheter was not able to advance further from the thrombus.¿the blood vessel stretched¿ but the embotrap was not able to be retracted.As a result, the microcatheter was removed from the patient and a 3 max thrombectomy catheter was used to remove the embotrap.After that, reopening was confirmed by angiography.There was minimal occlusion in the branch but the procedure completed without any further treatment because they were peripheral.There were no symptoms such as bleeding and dissection reported.Per the physician, potential factors that might have contributed to the withdrawal difficulty was that the embotrap might have stuck on plaque or the thrombus was hard.He is unsure because the exact time of occurrence of the event is unknown.The device was discarded; therefore, no further investigation can be performed.A review of the manufacturing documentation associated with lot number 20d088av presented no issues during the manufacturing or inspection process that can be related to the reported event.Withdrawal difficulty is a known potential complication associated with the embotrap revascularization device.The ifu also warns the user to not withdraw the device against significant resistance.The cause of the resistance should be assessed using fluoroscopy and the microcatheter should be advanced over the device to resheath or partially resheath to aid in withdrawal.The root cause of the event cannot be conclusively determined based on the information available for review; however, it is likely that clinical and procedural factors, including clot burden, vessel characteristics and excessive device manipulation, may have contributed.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.

Manufacturer Narrative

Product complaint #(b)(4).Coding correction.Health effect impact code: modified surgical procedure to be removed and replaced with health impact code: no patient consequence.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received confirmed that the blood vessel stretched as the embotrap was attempted to be retracted.The clot was retrieved by the 3 max thrombectomy catheter.

• 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: 11358839
• MDR Text Key: 243983409
• Report Number: 3011370111-2021-00016
• 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,Followup,Followup
• Report Date: 02/02/2021

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 Expiration Date: 03/05/2023
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 20D088AV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 03/22/2021; 04/30/2021; 05/06/2021
• Supplement Dates FDA Received: 04/09/2021; 04/30/2021; 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 MAX THROMBECTOMY CATHETER; MARKSMAN CATHETER
• Patient Age: 82 YR