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

Model Number	M003UZAS30210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the stent assisted coiling procedure for aneurysm located in the acom, the radiopaque marker of the subject stent delivery wire detached and fell off in the micro catheter.Physician didn't felt anything abnormal during the withdrawal of the delivery wire but noticed it while tracking up his first coil through the micro catheter.Surgical delay of more than 30 minutes was reported during the procedure.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the stent assisted coiling procedure for aneurysm located in the acom, the radiopaque marker of the subject stent delivery wire detached and fell off in the micro catheter.Physician didn't felt anything abnormal during the withdrawal of the delivery wire but noticed it while tracking up his first coil through the micro catheter.Surgical delay of more than 30 minutes was reported during the procedure.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received.The reported lot number was not confirmed as the packaging was not returned with the device.During the visual inspection, there was a coil returned within the catheter.The sdw was kinked/bent and broken.The main coil returned was intact.The coil delivery wire was kinked.The catheter shaft was kinked.The stent was not returned as it was implanted.Functional testing was not done as the stent was deployed and remained in the patient.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.No anomalies were noted to the device prior to use and there is no indication of a use error from the information provided.An assignable cause of procedural factors will be assigned to the as analyzed sdw broken/fractured during use and sdw kinked/bent.The issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.The reported ro marker(s) detached/separated/not visible under fluoroscopy was not confirmed during analysis as the stent was implanted successfully and the markers are located on the stent.The sdw was broken which may have been perceived as the stent ro marker was detached.An assignable cause of not confirmed will be assigned to the as reported ro marker(s) detached/separated/not visible under fluoroscopy.

• Brand Name: NEUROFORM ATLAS 3.0MM 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
• MDR Report Key: 11572157
• Report Number: 3008881809-2021-00140
• Device Sequence Number: 17024547
• Product Code: NJE
• UDI-Device Identifier: 07613327382211
• UDI-Public: 07613327382211
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/23/2021

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: 01/25/2025
• Device Model Number: M003UZAS30210
• Device Catalogue Number: M003UZAS30210
• Device Lot Number: 22097538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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 MICRO CATHETER (STRYKER); TARGET COIL (STRYKER)