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

Model Number ET009533

Device Problems Fracture (1260); Material Twisted/Bent (2981); Premature Separation (4045)

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

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The initial reporter phone: (b)(6).Device evaluated by mfr: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The photo of the complaint device included was reviewed by the product analysis team and is documented below.[photo review]: review of the provided photograph shows evidence of separation of the embotrap device which confirms this aspect of the complaint event description.The complaint event description also described the ¿delivery wire was kinked/bent¿; the shaft of the embotrap device was photographed within the packaging hoop therefore this could not be confirmed from the provided photograph.The outer cage and inner channel show evidence of deformation in the provided photograph.No further damage or deformation was observed on the embotrap device in the provided photograph.The cause of the deformation present cannot be determined from the photograph provided.Conclusion: the review of the provided photograph confirms separation of the embotrap device into individual components.The root cause of the reported complaint event cannot be determined from the provided photograph.A review of the manufacturing documentation associated with this lot: (20f098av) 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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

It was reported that the complaint device, a 5mm x 21mm embotrap ii revascularization device (et007521 / 20f098av) was used during a product presentation in fluid model to demonstrate the thrombectomy process and the simulated thrombus was placed in the right middle cerebral artery (mca).The physician removed the embotrap ii device together with the intermediate catheter out from the fluid model and it was immediately observed that the stent body and the delivery wire were kinked / bent.It was reported that then, the whole stent body fell off from the delivery wire; the inner and outer cages / channels of the stent body were separated.There was no patient involvement as this was a product presentation.A photo of the complaint device was included in the complaint.On 16-mar-2023, additional information was received from the cerenovus sales representative via phone.The information indicated that the microcatheter used with the embotrap ii device was a microport microcatheter.A sofia¿ 6f intermediate catheter (microvention) was used.Adequate continuous flush was maintained through the catheter.During advancement, the physician encountered sight resistance at the tortuous end of the internal carotid artery.There was no difficulty deploying the device.The information indicated that the stent body became separated (fell off) of the delivery wire but did not break into two or more pieces.The guide catheter did not appear damaged.The embotrap ii device was used only for product demonstration; it was not used in patient.It was indicated by the additional information that another embotrap ii device was not opened to continue with the product demonstration.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to make a correction to the product code of the complaint device reported in the 3500a initial medwatch report.[corrected information]: on 11-apr-2023, the product analysis lab reported that the product received on 03-apr-2023 was not the 5mm x 21mm embotrap ii revascularization device (et007521) as reported in the complaint.The pouch the device was returned in belonged to an et007521, however, the product received was a 5mm x 33mm embotrap ii revascularization device (et009533).An email was sent to the china team to verify the product associated with the complaint.On 11-apr-2023, the following response was received from the china team: ¿confirmed with sales [rep] via phone that the correct product code for the complaint is 5x33mm instead of 5x21mm and the device was returned with the wrong pouch.¿ d.4: the expiration date of the device is not known as the device lot number is not available / not reported.H.4: the device manufacture date is not known as the device lot number is not available / not reported.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.Section d.1 brand name: the brand name has been corrected from embotrap ii 5x21 revasc.Dev.To embotrap ii 5x33 revasc.Dev.Section d.4 catalog: the catalog has been corrected from et007521 to et009533.Section d.4 unique identifier (udi): the udi has been corrected from (b)(4) to (b)(4).

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report an updated review of the photo included in the complaint and to report the investigation finding of the returned device.Photo review summary: review of the provided photograph shows evidence of separation of the embotrap device which confirms this aspect of the complaint event description.The complaint event description also described the ¿delivery wire was kinked/bent¿; the shaft of the embotrap device was photographed within the packaging hoop therefore this could not be confirmed from the provided photograph.The outer cage and inner channel show evidence of deformation in the provided photograph.No further damage or deformation was observed on the embotrap device in the provided photograph.The cause of the deformation present cannot be determined from the photograph provided.Phot review conclusion: the review of the provided photograph confirms separation of the embotrap device into individual components.The root cause of the reported complaint event cannot be determined from the provided photograph.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: the embotrap device was returned in a disassembled state.The outer cage and inner channel components were returned disengaged from the device shaft.Examination of the returned embotrap outer cage showed evidence of kinking of the floating crown struts of the device.The proximal and distal collars of the outer cage showed no evidence of damage or deformation.Examination of the embotrap inner channel showed evidence of a fracture of the spring feature of the inner channel.The distal extended strut of the inner channel was not present on the returned inner channel.This part of the inner channel is covered by the distal coil and adhesively bonded in place when the device is fully assembled.The distal coil of the device was not present in the returned materials; it is possible that the missing piece of the inner channel spring feature and extended strut distal of the fracture identified remained bonded to the distal coil, which was lost following disengagement of the embotrap device.The fracture face of the spring feature shows no evidence of material fault or polishing, indicating that the fracture is not a result of an inclusion or pre-existing fracture and occurred after the manufacturing of the embotrap device.The proximal c-shaped collar of the inner channel showed no evidence of damage or deformation.The embotrap gold markers, showed no evidence of damage or deformation.The proximal coil showed no evidence of damage or deformation.The distal coil of the device was not returned, and therefore could not be inspected.The nitinol shaft showed evidence of minor damage to the coating of the device.The distal step of the shaft (which forms part of the proximal bond of the device) showed no evidence of damage or deformation.The proximal bond also showed evidence of adhesive present, indicating that the proximal bond was initially formed correctly.The polytetrafluoroethylene (ptfe) insertion tool was dimensionally inspected and found to be within specification for the inner and outer diameter.A number of indentations were observed along the length of the insertion tool, one of which located near one of the tips of the insertion tool prevented full insertion of a 0.025-inch pin gauge (note: the pin inserted up to this point, indicating that without the presence of the indentation the pin gauge would have passed through fully).The complaint event description did not indicate how many uses the returned device underwent prior to the complaint event.As this event occurred during demonstration of the product in a flow model and not used in a clinical setting for a mechanical thrombectomy procedure, it is unknown if the same controls and conditions were present which would be in place under normal use conditions.The observations made during the visual inspection may be a result of multiple uses: ¿ the insertion tool indentations may be a result of handling of the insertion tool over multiple uses (multiple closures of a rotating hemostasis valve (rhv), kinking of the insertion tool when handling).The minor damage to the ptfe coating at the proximal end of the shaft may be a result of multiple uses outside of that recommended in the instructions for use (ifu) (3 passes) where a torque device was placed and removed from the proximal end of the shaft multiple times.The adhesive used in the proximal and distal bond is normally in contact with fluid for a short period lasting minutes during the procedure, the ifu states that the device may be left to embed in the clot 3-5 minutes prior to withdrawal of the device.If the returned device was reused as demonstration product multiple times and over a number of days, resulting in the bonds being wetted multiple times and for an extended period, this may have impacted the adhesive bonds present, and contributed to failure of the bonds.Under normal use this is not applicable, as a new device is opened for each procedure, and the procedural time would not be long enough to cause this affect.Failure of the distal adhesive bond has the potential to permit the inner cage to move distally relative to the outer cage.This stretching of the inner cage would apply a tensile load to the inner cage which may have caused the fracture seen on the distal coil of the inner cage, resulting in the disassembly of the inner cage from the distal bond.Failure of the proximal adhesive bond may have allowed the shaft step at the proximal bond to move forward relative to the proximal collar of the outer cage, resulting in the inner cage half round collar to become disengaged from the shaft step and separation of the proximal bond.While this hypothesis for the device separation cannot be confirmed from the complaint information provided, the review of the returned unit confirmed the presence of adhesive in the bond locations which concludes the device was manufactured correctly.Investigation conclusion: the embotrap device was returned in a disassembled state.The outer cage and inner channel were disengaged from the device shaft, and the distal coil of the device was not returned.The outer cage component showed evidence of kinking of the floating crown struts.The inner channel component was fractured on the spring feature, with part of the inner channel, including the section of the inner channel which is covered by and bonded to the distal coil, not present or returned.The fracture face of the spring feature showed no evidence of material fault or polishing, indicating this was not a result of a material fault or a pre-existing fracture, and occurred after the manufacturing of the embotrap device.The features of the inner channel and outer cage components which form part of the proximal and distal bonds showed no evidence of damage or deformation.The distal step of the shaft which forms part of the proximal bond showed no evidence of damage or deformation.Minor coating damage was observed on the shaft of the returned device.A number of indentations were observed on the returned ptfe insertion tool.A visual inspection of the ancillary devices used during the complaint event was not possible as these were not returned or specified.Based on the visual inspection of the returned device components, the cause of the complaint event cannot be confirmed.The observations made during the visual inspection could be a result of multiple device uses, but information regarding this was not specified in the complaint event description therefore this cannot be confirmed.The complaint event occurred during a demonstration of the product, therefore the controls and conditions in place when storing, preparing, and testing the product cannot be confirmed.The returned components of the embotrap device showed evidence of correct manufacturing / assembly.There is no indication that this complaint was a result of a defect or malfunction of the embotrap device.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 03-apr-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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; 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16595177
• MDR Text Key: 312298902
• Report Number: 3011370111-2023-00036
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/04/2023

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: 04/15/2023
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 20F098AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 04/03/2023; 04/11/2023; 05/04/2023
• Supplement Dates FDA Received: 04/03/2023; 04/12/2023; 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2020
• 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
• Treatment: MICROCATHETER (MICROPORT); SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION)