MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30210

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

Patient Problems Intracranial Hemorrhage (1891); Thrombosis/Thrombus (4440)

Event Date 01/22/2024

Event Type  Injury  

Event Description

It was reported that during the left anterior communicating artery (acom artery) aneurysm case, subject stent got prematurely and partially deployed from a position more distal than the expected implantation position.Thrombosis and bleeding were observed due to improper deployment of subject stent.Resistance was encountered when the partially deployed subject stent was withdrawn and prematurely deployed down to the internal carotid artery.As a medical intervention, an additional stent was implanted and a surgical delay of 120 min was observed.The procedure was completed successfully.The patient is stable without any medication.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, it was observed that the subject stent was not returned for analysis.The stent delivery wire (sdw) was found to be kinked/bent at 3cm, 34cm, 82cm 171cm from the distal tip.The stent introducer sheath was not returned for analysis.A functional inspection was unable to perform as subject stent was not returned.The reported event is covered in the device directions 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 stent delivery wire part of the subject stent was the only part returned.The as reported 'stent deployed prematurely during use' and 'stent failed/unable to deploy' were not able to be duplicated.The returned part of the device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the returned part of the device.Additional information provided by the customer indicated that the device was prepared as per the dfu.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 'average tortuosity'.It was reported that 'when deploying the stent from a2, the stent was deployed from a position more distal than the expected implantation position.The stent was withdrawn near the neck with half of the stent deployed, but resistance was encountered, and the stent was deployed with almost fully extended when the proximal marker withdrawn to the internal carotid artery.The stent near the neck was fully extended and straighten, and a foreign substance that appeared to be a marker was observed.Another stent was opened and implanted, so there are two delivery wires to be returned'.After the procedure the patient's condition was described as 'stable without any medication'.Regarding the foreign substance that appeared to be a radiopaque (ro) marker, in the follow-up good faith effort (gfe) answers the user provided additional information.They confirmed that the marker did not detach/separate, and they clarified that they did not say that it had remained in the anatomy.The subject stent was not returned for analysis as it had been implanted in the patient.The introducer sheath was also not returned for analysis.The stent delivery wire (sdw) was returned for analysis and was kinked/bent at several locations along its length.All of the follow-up gfe answers indicate that the introducer sheath was advanced sufficiently and the rhv was tightened to prevent inadvertent proximal movement of the sheath prior to or during stent transfer.The issue appears to have arisen due to the stent being partially deployed in an incorrect position, but it is unclear why the stent was in this incorrect position.One thing to note is that the neuroform atlas dfu states that if the stent accidentally deploys in the incorrect position, in general, the safest course of action is not to try repositioning the stent.Rather, continue to deploy the stent where it is and then deploy a second stent at the desired location.Safely deploying a stent ¿ even in an undesired location ¿ will minimize vascular injury.An assignable cause of procedural factors has been assigned to the 'as reported' codes 'patient vessel thrombosis' and 'patient intracranial hemorrhage'.While the reported vessel thrombosis and intracranial hemorrhage are anticipated outcomes from this type of procedure, in this case it can most likely be attributed to the attempt to withdraw the partially deployed stent and the resistance encountered.An assignable cause of undeterminable has been assigned to the 'as reported' codes 'stent deployed prematurely during use' and 'stent failed/unable to deploy' as these parts of the device were not returned and it is not possible to view the sdw and say with any certainty how the damage to the sdw is linked to these two as reported codes.An assignable cause of procedural factors as been assigned to the 'as analysed' code 'sdw kinked/bent' as this complaint appears to be associated with a product that met the manufacturers design and manufacturing specifications, but performance was limited due to procedural factors during use.

Event Description

It was reported that during the left anterior communicating artery (acom artery) aneurysm case, subject stent got prematurely and partially deployed from a position more distal than the expected implantation position.Thrombosis and bleeding were observed due to improper deployment of subject stent.Resistance was encountered when the partially deployed subject stent was withdrawn and prematurely deployed down to the internal carotid artery.As a medical intervention, an additional stent was implanted and a surgical delay of 120 min was observed.The procedure was completed successfully.The patient is stable without any medication.

• Brand Name: NEUROFORM ATLAS 3.0MM 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: 18684268
• MDR Text Key: 335106752
• Report Number: 3008881809-2024-00059
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 22921538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Outcome(s): Required Intervention; Other