MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.

Catalog Number ET007533

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.There were kinked struts on the inner channel and kinked struts on the outer cage of the embotrap (et007533, 19a161av), meeting regulatory reporting criteria.Also, additional event information received on 9/10/2019 resulted in a change in the reportability of this complaint.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3011370111-2019-00152.Complaint conclusion: as reported by a healthcare professional, during an intra-arterial thrombectomy to the carotid and m1 occlusion, there was some difficulties in advancing a 5x33 embotrap ii revascularization device (et007533, 19a161av).Through the first orion21 microcatheter (mc).Four attempts were made.Then a second 5x33 embotrap ii revascularization device (et007533, 19d071av) also had difficulties advancing through the second orion21 microcatheter (mc) and a trevo pro 18 mc.Both embotraps failed to advance through the microcatheter¿s hub.The target position was lost with both empotraps and microcatheters, but it was not difficult to regain.Assess was obtained in less 10 minutes position.They used a 6x25cm trevo xp provue stentretriever with the same trevo pro 18 microcatheter and the clot was successfully removed.There was a procedural delay of approximately 10 minutes with every change.There was no patient injury reported.The introducers were installed into the hub of the microcatheter during advancement as usual.Adequate and continuous flush was maintained through the catheters.When the devices were removed from the patient, there was no actual damage on any part of the devices.The initial examination of the returned embotrap device (et007533, 19a161av)) identified deformation of the proximal struts (outer cage and inner channel) but there was no evidence of any strut fractures.The visual inspection also indicates that the return embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The damage noted during the visual inspection under magnification i.E.Kinked proximal struts on both the outer cage and inner channel is indicative of excessive pushing of the device against resistance.The damage to the proximal struts is indicative of a blockage or constriction of the inner lumen of the microcatheter or pre-deployment of the device in the microcatheter hub as the insertion tool may not have been fully seated.The return embotrap device was successfully passed through a 0.0195¿ tube, confirming that the profile conformed to the specification for compatibility with 0.021¿ microcatheters.The ptfe insertion tool was dimensionally inspected and found to be within specification for the outer diameter (od).The damage to the return embotrap device is consistent with attempted delivery into a microcatheter against significant resistance.The most probable causes of the failure to advance through the microcatheter are either: a) a failure to seat the insertion tool fully into the microcatheter hub prior to advancing the device (a failure to maintain the insertion tool in a fully seated position whilst advancing the device) b) a constriction in the microcatheter hub/lumen, likely to be located at the interface of the microcatheter hub and shaft.Device insertion and delivery assessments were performed using the return embotrap device and a sample orion and trevo pro 18 microcatheter, however the returned device failed to advance from the insertion tool into the lumen of the microcatheters that were outlined when the device was returned.A new embotrap was then advanced with no noted resistance and successfully delivered through the entire length of each of the microcatheters.This was confirmed with the insertion tool fully seated in the microcatheter hub and also with gaps (i.E.Distance from the distal end of the insertion tool to the lumen at the proximal end of the microcatheter shaft) of up to 10mm and 12mm in the orion and the trevo pro 18 microcatheters respectively.Advancement was unsuccessful at a gap greater than 12mm and 15mm, i.E.Incorrectly seated.The complaint indicated that the physician used 2 embotraps and was unable to deliver either device in the microcatheters as detailed above.Due to only a single embotrap being returned, this device was evaluated in both microcatheters outlined in the complaint as it was not indicated which microcatheter this device was used with.The returned device was unsuccessfully passed through an orion or trevo pro 18 microcatheter leading to failure to deliver the embotrap device.Another new embotrap was taken and successfully passed through both the orion and trevo pro 18 microcatheters.The reported customer complaint ¿embotrap - impeded in mc with loss of cerebral target position ¿ was confirmed as the damage is consistent with attempted delivery through a constricted lumen the most probable root cause(s) therefore is either a localized temporary constriction in the proximal end of the microcatheter existed that prevented delivery of the return embotrap device (i.E.Such as a kink or constriction in the lumen potentially due to excessive angulation of the proximal end of the microcatheter) or the rhv seal was not fully tightened thereby allowing some movement of the insertion tool in the rhv during device delivery.Per the instructions for use (ifu), insert the distal end of the insertion tool through the rhv of the microcatheter and wait until fluid is seen exiting the proximal end of the insertion tool, confirming that the device is flushed.Advance the insertion tool until it is fully seated in the hub of the microcatheter.Fully tighten the rhv to hold the insertion tool securely in position.Confirm that the insertion tool is fully seated in the hub of the rhv before proceeding to advance the device.Advance the device until at least half of the shaft length has been inserted into the microcatheter, at which point the insertion tool may be removed.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 an intra-arterial thrombectomy to the carotid and m1 occlusion, there was some difficulties in advancing a 5x33 embotrap ii revascularization device (et007533, 19a161av).Through the first orion21 microcatheter (mc).Four attempts were made.Then a second 5x33 embotrap ii revascularization device (et007533, 19d071av) also had difficulties advancing through the second orion21 microcatheter (mc) and a trevo pro 18 mc.Both embotraps failed to advance through the microcatheter¿s hub.The target position was lost with both empotraps and microcatheters, but it was not difficult to regain.Assess was obtained in less 10 minutes position.They used a 6x25cm trevo xp provue stentretriever with the same trevo pro 18 microcatheter and the clot was successfully removed.There was a procedural delay of approximately 10 minutes with every change.There was no patient injury reported.The introducers were installed into the hub of the microcatheter during advancement as usual.Adequate and continuous flush was maintained through the catheters.When the devices were removed from the patient, there was no actual damage on any part of the devices.Based on the product analysis for the first embotrap (et007533, 19a161av), there was kinked struts on the inner channel and kinked struts on the outer cage.

Manufacturer Narrative

(b)(4).Common device name: catheter, thrombus retriever.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: EMBOTRAP II
• Manufacturer (Section D): NEURAVI LTD.; block 3, ballybrit business pa; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 9050298
• MDR Text Key: 197812249
• Report Number: 3011370111-2019-00153
• Device Sequence Number: 1
• Product Code: NRY
• 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: 07/03/2019

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: 11/11/2021
• Device Catalogue Number: ET007533
• Device Lot Number: 19A161AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC ORION MICROCATHETER; BOSTON SCIENTIFIC ORION MICROCATHETER; EMBOTRAP II 5X33 REVASC. DEV.; STRYKER TREVO PRO MICROCATHETER