MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 24MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003UZAS40240
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The stent (subject device) was returned for analysis, and it was discovered that the stent (subject device) was returned deployed within the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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.During visual inspection, the device was returned with part of a stryker microcatheter, the sdw (stent delivery wire) was seen to be kinked, the stent was seen to be deformed, and the introducer sheath was not returned.During a functional test, to determine if the stent had deployed inside the catheter shaft, a mandrel was advanced through the returned segment of the catheter with the deployed stent pushing through the catheter 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 event can be confirmed, as the damage noted to the returned device is indicative of the reported event.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that, the stent was stuck in the microcatheter.The device was returned and the sdw (stent delivery wire) was noted to be kinked, the stent was returned deployed within a stryker microcatheter and was noted to be deformed once removed, confirming the reported event.It is probable that the stent was deformed as a result of the difficulty experienced in advancing the stent through the microcatheter and causing the subsequent premature stent deployment within the microcatheter.An assignable cause of procedural factors will be assigned to the reported ¿stent difficult/unable to advance or pullback through catheter¿ and to the analyzed ¿sdw kinked/bent¿, ¿stent deformed¿ and ¿stent deployed prematurely during use¿, 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 and/or anatomical factors during use.

• Brand Name: NEUROFORM ATLAS 4.0MM X 24MM 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: 16212085
• Report Number: 3008881809-2023-00028
• Device Sequence Number: 17549669
• Product Code: NJE
• UDI-Device Identifier: 07613327382167
• UDI-Public: 07613327382167
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 01/19/2023

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: 05/17/2026
• Device Model Number: M003UZAS40240
• Device Catalogue Number: M003UZAS40240
• Device Lot Number: 22921969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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: SL-10 CATHETER (STRYKER MANUFACTURER)
• Patient Sex: Unknown