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

Catalog Number	M003UZAS45300
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The stent (subject device) was returned for analysis and it was discovered that the subject stent was prematurely deployed during use.The subject device was replaced, and 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 stent was found to be stuck inside of the microcatheter.The stent was found to be deformed.The sdw (stent delivery wire) and stent introducer sheath were not returned.A functional inspection was not performed as the stent was found to be deployed in the, primary strain relief of an microcatheter.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 complaint was not confirmed based on analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the stent deployed within the hub of the microcatheter while advancing in the introducing sheath.The device was returned for analysis, and it was noted that the stent was found to be stuck inside of the microcatheter.The stent was found to be deformed.The stent delivery wire and stent introducer sheath was not returned.During functional inspection, the stent was found to be deployed in the primary strain relief of a microcatheter.The reported event 'stent deployed prematurely during transfer' was not confirmed during the analysis and will be assigned a probable cause of not confirmed.The as analyzed codes: 'stent deployed prematurely during use' and 'stent deformed' will be assigned a probable cause of 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 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
• 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: 20268028
• Report Number: 3008881809-2024-00434
• Device Sequence Number: 17952150
• Product Code: NJE
• UDI-Device Identifier: 07613327382129
• UDI-Public: 07613327382129
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/20/2024

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 Catalogue Number: M003UZAS45300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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).
• Patient Sex: Unknown