MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40210

Device Problems Premature Activation (1484); Activation Failure (3270)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

During a neurovascular procedure physician used a balloon to dilate the target vessel first.The balloon was then deflated and maintained in the target location.The physician then delivered the subject stent through the balloon catheter to the target lesion.The physician withdrew the balloon catheter to deploy the subject stent and after 2-3mm tip of the subject stent was deployed out, it was found that this segment did not expanded.The three markers on the subject stent were not expanded.The operator continued to withdraw the balloon catheter to deploy the subject stent, but resistance was encountered and the subject stent could not be deployed.The operator tried to retract the subject stent but could not retract the subject stent back into balloon catheter.Finally the operator withdrew the subject stent out together with the balloon catheter.The subject stent and balloon catheter were replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

During a neurovascular procedure physician used a balloon to dilate the target vessel first.The balloon was then deflated and maintained in the target location.The physician then delivered the subject stent through the balloon catheter to the target lesion.The physician withdrew the balloon catheter to deploy the subject stent and after 2-3mm tip of the subject stent was deployed out, it was found that this segment did not expanded.The three markers on the subject stent were not expanded.The operator continued to withdraw the balloon catheter to deploy the subject stent, but resistance was encountered and the subject stent could not be deployed.The operator tried to retract the subject stent but could not retract the subject stent back into balloon catheter.Finally the operator withdrew the subject stent out together with the balloon catheter.The subject stent and balloon catheter were replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection:the device was returned.The stent was returned in a deployed state.The sdw tip was found to be kinked/bent.The stent was found to be deformed.The stent introducer sheath was not returned for analysis.Functional inspection: stent failed/unable to open - a functional inspection could not be performed as the stent was returned in a deployed state.Stent failed/unable to deploy - a functional inspection could not be performed as the stent was returned in a deployed state.Stent partial deployment - a functional inspection could not be performed as the stent was returned in a deployed state.The reported event is covered in the device direction for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The as reported (ar) codes 'stent failed/unable to open', 'stent failed/unable to deploy' and 'stent partial deployment' could not be duplicated as the stent was returned in a fully deployed state.However, the analysis results are consistent with the reported event.The returned device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received from the customer indicates that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was described as 'moderately tortuous'.It was reported that 'during an ica (internal carotid artery) stenosis case.Used a balloon to dilate first and then deflated the balloon and maintain the location of it and then delivered a atlas stent along with the balloon catheter to the lesion.Then withdrew the balloon catheter to deploy the stent and after 2-3mm tip of the stent was deployed out, this segment was found not expanded.The three markers were not expanded.The operator continued to withdraw the balloon catheter to deploy the stent and then big resistance was encountered and the stent could not be deployed.The operator then tried to retract the stent but the stent could not be retracted back into balloon catheter.Finally the operator withdrew the stent system and balloon catheter out together and replaced them with a microcatheter and a new stent to finish the procedure'.Note: the atlas device was being used in an ica stenosis case.Per the neuroform atlas dfu, 'the neuroform atlas stent system is indicated for use with bare metal embolic coils for the treatment of wide-neck intracranial, saccular aneurysms'.When asked to explain why a gateway balloon was sued in an attempt to deploy the atlas stent the operator replied that they felt 'the lumen of gateway allows the passing of atlas stent.He did this before and it worked.He also felt using gateway to deliver stent could reduce the process and increase the safety of the surgery'.The stent will be returned with condition of completely deployed but it was not deployed prematurely during the procedure inside patient's body.It was pushed out after the procedure by operator on purpose.The stent was returned for analysis fully deployed.The stent was deformed towards the distal (open cell) end.The 3 marker bands were present on both ends of the returned stent.The stent delivery wire (sdw) was also returned for analysis and was seen to be slightly bent near the distal end of the wire.The introducer sheath was not returned for analysis.As per the neuroform atlas dfu, the atlas stent should be advanced through a stryker neurovascular 0.0165-0.017 in (0.42-0.43 mm) id microcatheters, excluding tracker¿ 17.It is probable that the stent and sdw were damaged as a result of advancing the stent through the incompatible gateway otw balloon catheter, causing the reported event.While the gateway catheter id is within recommended specification (at 0.0166"), the catheter tip id is 0.0100".This is likely to lead to issues when attempting to deploy the stent.In addition, the internal profile of the gateway hub is not ideal for transfer ot the atlas stent from the introducer sheath into the catheter lumen.Selection of the gateway balloon catheter is likely to have been a significant contributory factor in the difficulties reported when attempting to deploy the atlas stent in this instance.An assignable cause of use error has been assigned to the as reported, stent failed/unable to open', 'stent failed/unable to deploy' and 'stent partial deployment'.And as analysed, sdw kinked/bent and stent deformed.This complaint appears to be associated with a product that met the manufacturers design and manufacturing specifications.However, there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.

• Brand Name: NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 19006743
• MDR Text Key: 339333735
• Report Number: 3008881809-2024-00137
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS40210
• Device Lot Number: 24297792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2023
• 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: GATEWAY BALLOON (STRYKER)
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Race: Asian