MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 30MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003UZAS45300
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection found that the sl10 lot number was seen on the device hub.The stent delivery wire (sdw) was seen to be kinked/bent.The stent was returned deployed in the microcatheter.The stent was seen to be deformed and the introducer sheath was intact.Functional inspection show that the stent was found to be deployed inside the catheter, a patency mandrel was used to advance the stent out.The reported event could not be confirmed; however, the analysis results are consistent with the reported event.The as analyzed sdw kinked/bent, stent deployed prematurely during use and stent deformed will be assigned to this investigation.The reported event is covered in the device directions for use 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.Additional information provided by the customer indicated that the device was in good condition during preparation/prior to use on the patient and continuous flush was maintained throughout the clinical procedure.The sdw was kinked bent, the stent returned with the sl-10 microcatheter and was found to be was deformed.Based on the event description and analysis the as reported can be confirmed.The as reported as well as the as analyzed listed in the grid below will be assigned procedural factors for stent deployed prematurely during use as this complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
Analysis of the returned device found that the subject stent prematurely deployed during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: NEUROFORM ATLAS 4.5MM X 30MM 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
• MDR Report Key: 12527117
• Report Number: 3008881809-2021-00392
• Device Sequence Number: 4460190
• Product Code: NJE
• UDI-Device Identifier: 07613327382129
• UDI-Public: 07613327382129
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/24/2021

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: 08/23/2024
• Device Model Number: M003UZAS45300
• Device Catalogue Number: M003UZAS45300
• Device Lot Number: 21701175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICROCATHETER (STRYKER)
• Patient Age: 66 YR