MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP- PMA; INTRACRANIAL COIL-ASSIST STENT

Catalog Number	M003UZAS30150
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent stenting procedure of the posterior inferior cerebellar artery (pica) aneurysm.During deployment, one of strands extended beyond the proximal landing zone after the subject stent wouldn't open up.The physician tried to agitate the proximal end of the subject stent that wasn't opening and the procedure was completed.The subject stent remains implanted in the patient.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM NO TIP- PMA
• Common Device Name: INTRACRANIAL COIL-ASSIST STENT
• 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: 24886759
• Report Number: 3008881809-2026-00224
• Device Sequence Number: 10330531
• Product Code: QCA
• UDI-Device Identifier: 07613327382228
• UDI-Public: (01)07613327382228(17)300720(10)25739057
• 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,Followup
• Report Date (Section B): 07/01/2026

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: M003UZAS30150
• Device Lot Number: 25739057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2025
• 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: SL10 MICROCATHETER STRAIGHT (STRYKER).
• Patient Sex: Unknown