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

Catalog Number M003EZAS40210

Device Problem Premature Activation (1484)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that during a neurovascular procedure, the operator used a microcatheter to deliver the subject stent.When attempting to deploy the stent, the operator mistakenly deployed the subject stent inside the microcatheter and the whole system migrated to lower location of aneurysm.Therefore the operator withdrew the subject stent and microcatheter out together and pushed the stent out of the microcatheter on the table.The subject stent was 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 inspections: the sdw (stent delivery wire) was seen to be kinked at 173cm from the proximal end.There was no damage noted to the introducer sheath.The stent stent was not returned.Functional inspection: pass, introducer sheath distal tip was seated nicely into the demo microcatheter hub.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 'stent deployed prematurely during use' was visually (indirectly) confirmed during inspection (it was not present still loaded on the sdw and was not present in the introducer sheath).The reported 'stent migration inside microcatheter' could not be duplicated as the stent was not returned for analysis.However, 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.It was reported that 'the operator used a microcatheter to deliver the subject stent normally and when the operator was releasing the tension of the whole system, he mistakenly deployed the subject stent and the subject stent migrated to lower location of aneurysm.The operator then withdrew the subject stent and microcatheter out together from y valve and then pushed the subject stent out from microcatheter on the table.When the stent was pushing out, it ejected it out and then was missing.Placed the microcatheter again and then delivered another stent to finish the procedure.No impact to patient'.It was further reported in the follow-up process that the subject stent was deployed mistakenly inside the microcatheter.Having pushed the stent out of the microcatheter, the same microcatheter was then used to complete the procedure.The stent was not returned for analysis.The introducer sheath was returned and was undamaged.The stent delivery wire (sdw) was also returned separately (not loaded inside the introducer sheath) and was kinked/bent at a single location along its length.Based on the event description and the additional information provided during the follow-up process, it is most likely that this issue occurred as a result of a user error.The lack of damage noted to the introducer sheath suggests that the sheath was set up correctly and the stent would have been transferred into the microcatheter without incident.The kink noted to the sdw could have occurred when the microcatheter had been removed from the patient and the stent was being pushed out of the microcatheter lumen.The user reported that they mistakenly deployed the subject stent inside the microcatheter lumen.Therefore, an assignable cause of user error has been assigned to the 'as reported stent deployed prematurely during use' and 'stent migration inside microcatheter' and as analyzed sdw kinked/bent and sent deployed prematurely during use 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 the investigation notes that 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.

Event Description

It was reported that during a neurovascular procedure, the operator used a microcatheter to deliver the subject stent.When attempting to deploy the stent, the operator mistakenly deployed the subject stent inside the microcatheter and the whole system migrated to lower location of aneurysm.Therefore the operator withdrew the subject stent and microcatheter out together and pushed the stent out of the microcatheter on the table.The subject stent was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 19093600
• MDR Text Key: 340567898
• Report Number: 3008881809-2024-00159
• 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: 05/08/2024

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: M003EZAS40210
• Device Lot Number: 24186155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2023
• 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: SL-10 MICROCATHETER (STRYKER)