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

Model Number ET009533

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The product lot number was not reported.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.As reported by a healthcare professional, during a thrombectomy, a 132cm large bore 71 catheter (ic71132ug, unknown lot) collapsed after the stent retriever removal.Also, the 5x33 embotrap ii revascularization device (et009533, unknown lot) was extremely long in size and shape which may have impacted ease of retrieval into large bore catheter (lbc).Severe damage to stent retriever as well (twisted and misshapen).The treatment area was to the right carotid artery terminus; 1cm estimated clot length; lbc achieved tici 3 with pass 1; no balloon guide catheter used; hard, sticky, fibrin rich clot.There was no report of patient injury.Pictures of both devices have been received for further evaluation.The initial examination of the photographed embotrap device identified that the shaft was cut midway along the proximal coil and that the first outer cage segment was not fully expanded but there was no evidence of any strut fractures from the image.The visual inspection of the image also indicates that the embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The observation noted during the visual inspection from the image i.E.The first segment of the embotrap not being fully expanded looks to be in part due to a significant amount of thrombus and blood remaining in this area.The complaint indicated that the photographed embotrap device was withdrawn into a large bore catheter.During this, the large bore catheter collapsed.The complaint mentioned that the device was twisted and misshapen, however, from the image received the device does not look twisted only that the first segment is not fully expanded due to the clot around this area.The investigation determined that the damage caused to the large bore catheter is consistent with its withdrawal through a closed rhv.The root cause for the non-fully expanded embotrap ii device is therefore concluded to be due to an entanglement of the outer cage, inner channel and blood clot due to the compressive force caused by the rhv.Such entanglement can be resolved by the standard thrombus removal technique described in the instructions for use (ifu).The lot number for the embotrap is not known; therefore, a device history record review cannot be completed.The image of the embotrap device exhibits the first segment not fully deployed with some clot and blood in the area.Although a visual examination of the device used during this complaint was not possible as the device was not returned for investigation, the root cause is concluded to be an entanglement of the outer cage and inner channel within the clot burden caused by the withdrawal of the large bore catheter and the embotrap device through a closed rhv.There is no indication that this complaint was as a result of a defect with the embotrap device nor that the entanglement is a permanent deformation of the device.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the images provided; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, clot size and vessel characteristics (i.E.Hard, sticky, fibrin rich clot) may have contributed to the reported failure and the damages visually observed on the images provided.If information is provided at a later date, the file will be reopened and processed accordingly.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.

Event Description

As reported by a healthcare professional, during a thrombectomy, a 132cm large bore 71 catheter (ic71132ug, unknown lot) collapsed after the stent retriever removal.Also, the 5x33 embotrap ii revascularization device (et009533, unknown lot) was extremely long in size and shape which may have impacted ease of retrieval into large bore catheter (lbc).Severe damage to stent retriever as well (twisted and misshapen).The treatment area was to the right carotid artery terminus; 1cm estimated clot length; lbc achieved tici 3 with pass 1; no balloon guide catheter used; hard, sticky, fibrin rich clot.There was no report of patient injury.Pictures of both devices have been received for further evaluation.

Manufacturer Narrative

Product complaint #: (b)(4).Corrected data: section b3: event date was (b)(6) 2020.Section b5: additional information was received that the patient was discharged the next day, and was doing extremely well.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 9818247
• MDR Text Key: 221295555
• Report Number: 3011370111-2020-00023
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• 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: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 132CM LARGE BORE 71 CATHETER