MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30150

Device Problem Premature Activation (1484)

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

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that during aneurysm procedure the operator used the microcatheter to deliver the subject stent.However, during the delivery the subject stent deployed inside the microcatheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the device was returned with the microcatheter.The stent was found to be in its pre - deployed state loaded with the stent delivery wire (sdw) into the microcatheter.The distal part of the sdw was found to be kinked/bent.The stent was found to be intact.The stent introducer sheath was found to be intact.Functional inspection to test the reported event ¿stent deployed prematurely during use¿ was not performed as the event was not confirmed during visual inspection.The device was flushed, and the stent was deployed on the table without difficulties.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 reported event 'stent deployed prematurely during use' was not confirmed during inspection.The stent was noted to be still loaded on the stent delivery wire (sdw) inside the returned microcatheter.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to 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 'moderately tortuous'.It was reported that 'the operator used the microcatheter to deliver the subject stent.During delivery the stent deployed in the microcatheter so the operator withdrew the microcatheter and stent out together and used new microcatheter and stent to finish the procedure'.The stent was returned for analysis still loaded on the sdw inside the returned microcatheter.Following flushing, the stent was successfully deployed from the microcatheter without experiencing any difficulties.The introducer sheath was returned for analysis and was undamaged.The sdw was also returned for analysis and there was a single kink/bend present close to the proximal bumper.Given these findings, it is not clear what issue was experienced by the user on this occasion.However, the user is likely to have felt some feedback through handling of the sdw and presumed that this meant that the stent has become detached from the sdw.The only actual damage noted upon inspection was a kink/bent to the sdw itself.An assignable cause of not confirmed has been assigned to the reported event: ¿stent deployed prematurely during use' and an assignable cause of procedural factors has been assigned to the analyzed event: ¿sdw kinked/bent¿ as this complaint appears to be associated with a product that met the manufacturers design and manufacturing specifications and was reported to have been used in accordance with the dfu, but performance was limited due to procedural factors during use.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that during aneurysm procedure the operator used the microcatheter to deliver the subject stent.However, during the delivery the subject stent deployed inside the microcatheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM 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: 19053886
• MDR Text Key: 340345163
• Report Number: 3008881809-2024-00151
• 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: 05/16/2024

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 Catalogue Number: M003EZAS30150
• Device Lot Number: 24761433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2024
• 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: SYNCHRO GUIDEWIRE (STRYKER); XT-17 MICROCATHETER (STRYKER)
• Patient Sex: Female
• Patient Race: Asian