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

Catalog Number ET007533

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, race, ethnicity, and medical history were not provided.(b)(6).[conclusion]: the healthcare professional reported that during a mechanical thrombectomy procedure, the physician attempted to advance the 5mm x 33mm embotrap ii revascularization device (et007533 / 19d071av) inside the headway® 21 microcatheter (microvention), but the embotrap device could not be advanced.The procedure was extended; there was no report of any patient adverse event or complication.Another competitor stent was used.The product was returned for evaluation.The investigational finding is documented below.Investigation summary: the returned embotrap device underwent visual inspection.The initial examination of the returned embotrap device identified deformation of the distal cone (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 struts on the distal cone of both outer cage and inner channel, although minimal, is indicative of excessive pushing of the device against resistance.The damage to the struts of the distal cone 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 polytetrafluoroethylene (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 constriction in the microcatheter hub/lumen, likely to be located at the interface of the microcatheter hub and shaft.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).Device insertion and delivery assessments were performed using the return embotrap device and a sample headway® 21 microcatheter.The returned device was advanced from the insertion tool into the lumen of the headway® 21 microcatheter with no noted resistance and successfully advanced forward through the entire length of the microcatheter.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 15mm.Advancement was unsuccessful at a gap greater than 15mm, i.E.Incorrectly seated.The complaint indicated that a new device was successfully passed through the same microcatheter by the physician after the initial failure to deliver the embotrap device indicating that it is unlikely that a permanent constriction or occlusion existed in the microcatheter hub.The most probable root cause(s) would be that 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 rotating hemostasis valve (rhv) seal was not fully tightened thereby allowing some slippage of the insertion tool in the rhv during device delivery.A review of manufacturing documentation associated with this lot (19d071av) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.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.

Event Description

The healthcare professional reported that during a mechanical thrombectomy procedure, the physician attempted to advance the 5mm x 33mm embotrap ii revascularization device (et007533 / 19d071av) inside the headway® 21 microcatheter (microvention), but the embotrap device could not be advanced.The procedure was extended; there was no report of any patient adverse event or complication.Another competitor stent was used.The product was returned for evaluation which revealed that the embotrap device has kinked struts on the distal cone of both the outer cage and the inner channel.Based on the product analysis on 8/19/2019, this event has been deemed mdr reportable as a ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 9/2/2019.[additional information]: the healthcare professional reported that during a mechanical thrombectomy procedure, the physician attempted to advance the 5mm x 33mm embotrap ii revascularization device (et007533 / 19d071av) inside the headway® 21 microcatheter (microvention), but the embotrap device could not be advanced.The procedure was extended by 5 minutes, it was not considered significant as there was no patient adverse event or complication.It was reported that there was adequate and continuous flush maintained through the headway microcatheter; there was no kink or any visible damage on the microcatheter that could have caused the embotrap not to be able to advance.The same microcatheter was used with the replacement stent to complete the procedure.Updated sections: g.4, g.7, h.2, and h.10.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; ballybrit business park; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 8935652
• MDR Text Key: 209798723
• Report Number: 3011370111-2019-00145
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

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: 01/02/2022
• Device Catalogue Number: ET007533
• Device Lot Number: 19D071AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 09/02/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEADWAY® 21 MICROCATHETER (MICROVENTION)
• Patient Age: 48 YR
• Patient Weight: 110