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	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure that the subject stent came off the cusher wire during the procedure.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device 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 was the stent came off of the wire in the delivery catheter.No further information was received.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.H3 other text : device not available for evaluation.
Event or Problem Description
It was reported during the procedure that the subject stent came off the cusher wire during the procedure.The procedure was completed successfully with no clinical consequences to the patient.

• 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: 14197882
• Report Number: 3008881809-2022-00195
• Device Sequence Number: 13913724
• Product Code: NJE
• UDI-Device Identifier: 07613327382129
• UDI-Public: 07613327382129
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/01/2022

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: 09/30/2023
• Device Model Number: M003UZAS45300
• Device Catalogue Number: M003UZAS45300
• Device Lot Number: 20913571R
• 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: 03/29/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2018
• 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
• Patient Sex: Unknown