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

Model Number	M003UZAS40210
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure when the stent (subject device) was delivered through a microcatheter, it prematurely detached inside the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to manufacturer.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.He reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer was the subject stent was advanced through a non-stryker microcatheter and it prematurely deployed in the catheter.As per a statement in the supplied dfu regarding required microcatheters "stryker neurovascular microcatheters specifically excelsior® sl-10® (0.0165 in/0.42 mm id) or excelsior® xt-17¿ (0.017 in/0.43 mm id)." velocity has an internal diameter (id) of 025" which is larger than the recommended id for delivery of stents, as the internal diameter of the catheter is to large this may cause the stent to open too wide inside the microcatheter and the sdw- stent delivery wire would just slide through causing the reported stent premature deployment.Therefore, an assignable cause of user error will be assigned to the reported code since there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.It was also reported that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient, and that continuous flush was set up and maintained during the procedure.
Event or Problem Description
It was reported that during the procedure when the stent (subject device) was delivered through a microcatheter, it prematurely detached inside the catheter.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- PMA
• Common Device Name: 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: 14519974
• Report Number: 3008881809-2022-00250
• Device Sequence Number: 6428531
• Product Code: NJE
• UDI-Device Identifier: 07613327382174
• UDI-Public: 07613327382174
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P180031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: M003UZAS40210
• Device Catalogue Number: M003UZAS40210
• Device Lot Number: 21301183R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATLAS STENT (STRYKER).; VELOCITY MICROCATHETER (NON-STRYKER).
• Patient Sex: Unknown