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

Catalog Number M003EZAS30210

Device Problem Premature Activation (1484)

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

Event Date 12/30/2023

Event Type  malfunction  

Event Description

It was reported that during anterior communicating artery (acoma) aneurysm embolization procedure, the operator delivered the subject stent.However, the subject stent got stuck in microcatheter and could not be advanced out.The operator withdrew the delivery wire and the subject stent was missing.It was concluded that 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

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 returned together with the microcatheter device.It was confirmed by the complaint intake center (cic) that there is no allegation against microcatheter.The stent delivery wire (sdw) was found to be kinked/bent.The proximal part of the sdw was found to be loaded into the microcatheter and stuck.The stent was found to be deployed inside the microcatheter.The stent was found to be intact.The stent introducer sheath was not returned.Functional inspection to test the reported event ¿stent difficult/unable to advance or pullback through catheter¿ was not performed as the stent was found to be deployed inside the microcatheter.The device was flushed.The proximal end of the sdw was found to be loaded into the catheter.The sdw was stuck inside the microcatheter and could not be advanced or retracted due to damaged microcatheter.The microcatheter was cut and the sdw was removed.The patency mandrel was advanced through the distal end of the cut, distal part of the microcatheter and the stent was pushed out.Due to friction the sdw was kinked/bent further during the analysis.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 confirmed during inspection.The reported event 'stent difficult/unable to advance or pullback through catheter' could not be duplicated as the stent was returned already deployed inside a microcatheter.However, the analysis results are consistent with the reported event.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 delivered a stent system to go into the microcatheter and continued to deliver the stent.However, the stent got stuck in microcatheter and could not be pushed out.After several tries the stent was still not able to be advanced out from microcatheter.The operator withdrew the delivery wire and no stent was found at tip of delivery wire and the operator felt it might be left inside microcatheter.Finally, the operator replaced the stent and microcatheter with new ones to finish the procedure'.The stent was returned for analysis deployed (off the stent delivery wire) inside the distal section of the returned microcatheter.The stent was pushed out through the distal tip of the microcatheter using a patency mandrel inserted through the microcatheter.Once the stent was removed from the microcatheter it was inspected and noted to be undamaged.The stent delivery wire was returned for analysis still loaded inside the lumen of the microcatheter.The sdw was firmly stuck inside the microcatheter and needed to be removed by cutting the microcatheter.The sdw was noted to be kinked/bent at several locations along it's length.Some of this damage may have occurred during the attempts to free the sdw from the microcatheter.The introducer sheath was not returned for analysis.The event description indicates there was resistance while advancing the stent and sdw inside the microcatheter.It is most likely that, due to unknown procedural and/or anatomical factors the user experienced resistance while advancing the device though the microcatheter and, due to this resistance, the user applied force to try and advance the device through the microcatheter resulting in the damage noted.Furthermore, when attempting to retract the stent, the delivery wire slipped out of the stent, leaving the stent deployed inside the microcatheter.The reported events: ¿stent difficult/unable to advance or pullback through catheter' and 'stent deployed prematurely during use' as well as the analyzed events: stent deployed prematurely during use¿, ¿sdw kinked/bent¿ and ¿sdw friction¿ will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

Event Description

It was reported that during anterior communicating artery (acoma) aneurysm embolization procedure, the operator delivered the subject stent.However, the subject stent got stuck in microcatheter and could not be advanced out.The operator withdrew the delivery wire and the subject stent was missing.It was concluded that 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 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: 18553919
• MDR Text Key: 333380945
• Report Number: 3008881809-2024-00021
• 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: 03/05/2024

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: M003EZAS30210
• Device Lot Number: 24398519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2023
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Male
• Patient Race: Asian