MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003UZAS30240
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports h3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that the subject stent deployed prematurely during use in the microcatheter.It was noted that the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that the subject stent deployed prematurely during use in the microcatheter.It was noted that the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 lot number - corrected from 24025462 to 24035462.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection shows the sdw (stent delivery wire) was noted to be kinked/bent.The stent was returned deployed and noted to be deformed.The stent introducer sheath distal tip was noted to be damaged.A functional inspection could not be performed as the stent was deployed.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 confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information indicates there was not any damage noted to the packaging prior to opening the packaging, continuous flush was set up and maintained throughout the clinical procedure, the stent deployed while advancing the stent within the microcatheter, the introducer sheath was confirmed to be properly inserted all the way into the microcatheter prior to transfer, when advancing the stent within the microcatheter, the rhv (rotating hemostatic valve) was confirmed to be opened enough to allow passage of the device through without damage, excessive force was not applied at any point while advancing the stent within the microcatheter.The device was returned for analysis, and it was noted that the stent was deformed.The sdw was noted to be kinked/bent.The as reported/as analyzed code stent deployed prematurely during use and the as analyzed code sdw kinked/bent, stent deformed and stent introducer sheath distal tip damaged listed in the grid below will be assigned procedural factors 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 factors during use.

• Brand Name: NEUROFORM ATLAS 3.0MM 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: 17264477
• Report Number: 3008881809-2023-00337
• Device Sequence Number: 18113549
• Product Code: NJE
• UDI-Device Identifier: 07613327382204
• UDI-Public: 07613327382204
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 09/29/2023

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 Model Number: M003UZAS30240
• Device Catalogue Number: M003UZAS30240
• Device Lot Number: 24035462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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: EXCELSIOR SL-10 (STRYKER)
• Patient Sex: Unknown