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

Model Number ET009533

Device Problems Patient-Device Incompatibility (2682); Material Twisted/Bent (2981)

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

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No.: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The initial reporter phone: (b)(4).The initial reporter email address is not available.[conclusion]: the healthcare professional reported that during an early morning thrombectomy procedure with the target occlusion at the m1-m1 segment of the middle cerebral artery (mca), the 5mm x 33mm embotrap ii revascularization device (et009533 / 19l134av) was used; three passes were made but reperfusion was not achieved.When the physician attempted to make another pass, he found a 45-degree bend at the wire and stent joint.The physician stopped using the embotrap ii device to avoid the situation where the stent may become detached into the cerebral blood vessel.An approach was made with the solitaire¿ stent retriever (medtronic), but reperfusion was not achieved.The physician then employed the use of suction via the react¿ 68 catheter (medtronic) and reperfusion was achieved.There was no report of patient injury or any adverse event as a result of the reported issue.The embotrap ii device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the initial visual inspection of the inner channel and the outer cage of the proximal portion of the embotrap ii device which may indicate advancement of the device against some resistance.Visual inspection indicated strut kinks on the proximal outer cage and inner channel.No other significant visible damage was noted.There was no evidence of any strut fractures.The visual inspection also confirmed that the returned embotrap ii device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The coil offset at the distal portion of the proximal coil was noted during the visual inspection under magnification which also indicates advancement of the device against some resistance, but this is not unusual in a device that has been subjected to use.The returned embotrap ii 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 inner diameter and outer diameter.The returned insertion tool was dimensionally inspected and found to be within specification for the inner diameter and outer diameter.A sample embotrap ii device (05mm x 33mm) was advanced into a sample headway 21 microcatheter with the insertion tool fully seated in the microcatheter hub and then with various levels of inadequate seating (i.E.Varying the distance between the distal end of the insertion tool to the lumen at the proximal end of the microcatheter shaft).This was to demonstrate one of the potential causes of resistance which may cause the similar deformation at the proximal outer cage and the inner channel of a embotrap ii device.It was confirmed that significant resistance was noted at a gap between the insertion tool and microcatheter lumen of greater than 10mm, i.E.Incorrectly seated, an advancement into the microcatheter was unsuccessful.A sample of embotrap ii device (05mm x 33mm) was then observed under magnification during the attempted advancement into the microcatheter when there is inadequate seating of the insertion tool in the microcatheter hub (i.E.The distance from the distal end of the insertion tool to the lumen at the proximal end of the microcatheter shaft was approximately 10mm).It was noted that the part of the stent like assembly close to the distal end of the delivery wire deformed significantly at the point when the embotrap ii device could not be advanced any further.This area of the device corresponds to the area of deformation noted in the event reported.A review of the device history record (dhr) associated with this lot (19l134av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Investigation conclusion: the returned embotrap ii device exhibits key characteristic which is consistent with advancement of the device against resistance.A visual inspection of the microcatheter used during this complaint was not possible as the microcatheter was not returned for investigation.The most probable causes of the deformation noted on the joint part of the stent like assembly and the nitinol delivery wire of the embotrap ii device may be concluded to be force applied to the embotrap ii device against some resistance.The potential cause of resistance can be concluded to be due to the following: a) a failure to seat the insertion tool fully into the microcatheter hub prior to advancing the device resulting in pre-deployment of the device in the microcatheter hub.B) a failure to maintain the insertion tool in a fully seated position whilst advancing the device, resulting in pre-deployment of the device in the microcatheter hub.This can occur if the rotating hemostasis valve (rhv) seal was not fully tightened thereby allowing some movement of the insertion tool in the rhv during device delivery.C) a microcatheter defect, such as a blockage or constriction in the microcatheter hub/lumen, likely to be located at the interface of the microcatheter hub and shaft.(as the reported event suggested that the microcatheter was used successfully prior to and after the attempted 4th pass of the embotrap ii, this cause is considered unlikely in the event reported.) d) a localized, temporary constriction in the proximal end of the microcatheter that prevented delivery of the return embotrap ii device (i.E.Such as a kink or constriction in the lumen potentially due to excessive angulation of the proximal end of the microcatheter).These potential causes above commonly result in damage / deformation to the stent like assembly of the embotrap ii device.There is no indication that this complaint was as a result of a defect with the embotrap ii devices.Treatment failure is a known potential outcome associated with endovascular mechanical thrombectomy.The embotrap ii revascularization device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset.The root cause of the inability to achieve reperfusion after three embotrap passes cannot be determined.However, clot burden / characteristics and procedural factors may have contributed to the inability to achieve reperfusion with the embotrap ii device during the procedure.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.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.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 an early morning thrombectomy procedure with the target occlusion at the m1-m1 segment of the middle cerebral artery (mca), the 5mm x 33mm embotrap ii revascularization device (et009533 / 19l134av) was used; three passes were made but reperfusion was not achieved.When the physician attempted to make another pass, he found a 45-degree bend at the wire and stent joint.The physician stopped using the embotrap ii device to avoid the situation where the stent may become detached into the cerebral blood vessel.An approach was made with the solitaire¿ stent retriever (medtronic), but reperfusion was not achieved.The physician then employed the use of suction via the react¿ 68 catheter (medtronic) and reperfusion was achieved.There was no report of patient injury or any adverse event as a result of the reported issue.The reported embotrap ii device was returned to johnson & johnson japan and photographs of the complaint device were taken.The photos underwent review by the product analysis team.Per the lab team, there is no visible deformation or damage on the insertion tool or on the shaft of the embotrap ii device.The condition of the stent component of the device cannot be completely discerned as it was inside the insertion tool.Based on the photographs of the complaint device, the reported damage (a 45-degree bend at the wire and stent joint) could not be confirmed.The embotrap ii device was inside the insertion tool in the photographs.The complaint device was returned for evaluation.During the visual / microscopic inspection of the returned device, there were strut kinks on the proximal outer cage and inner channel and there was also proximal coil offset observed.Based on the product analysis that began on (b)(6) 2021 and completed on (b)(6) 2021, this event has been deemed mdr reportable as a ¿malfunction.¿.

• 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
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 11252600
• MDR Text Key: 231340286
• Report Number: 3011370111-2021-00011
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/15/2022
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 19L134AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1