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 Codes	Entrapment of Device (1212); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior communicating artery (acom) aneurysm treatment procedure, the physician delivered the subject stent through a microcatheter.Upon deployment it appeared that the distal end of the subject stent did not open.The physician continued to deploy the subject stent and the proximal end opened in the a1 segment.The distal end of the subject stent did not open.The physician encountered resistance when attempting to withdraw the stent delivery wire (sdw) but the sdw felt stuck in the distal segment of the subject stent.After further attempts to pull/ remove the sdw, it was successfully removed.The physician advanced a guidewire and a microcatheter to the distal end of the subject stent.When the microcatheter reached the distal end of the subject stent, the distal end sprung open and fully apposed.The procedure was completed successfully with no clinical consequences reported to the patient.The patient¿s condition was stable and was discharged from the hospital the next day.
Additional Manufacturer Narrative
H3 other text: the device is not available to the manufacturer.
Event or Problem Description
It was reported that during an anterior communicating artery (acom) aneurysm treatment procedure, the physician delivered the subject stent through a microcatheter.Upon deployment it appeared that the distal end of the subject stent did not open.The physician continued to deploy the subject stent and the proximal end opened in the a1 segment.The distal end of the subject stent did not open.The physician encountered resistance when attempting to withdraw the stent delivery wire (sdw) but the sdw felt stuck in the distal segment of the subject stent.After further attempts to pull/ remove the sdw, it was successfully removed.The physician advanced a guidewire and a microcatheter to the distal end of the subject stent.When the microcatheter reached the distal end of the subject stent, the distal end sprung open and fully apposed.The procedure was completed successfully with no clinical consequences reported to the patient.The patient¿s condition was stable and was discharged from the hospital the next day.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed due to the device was not returned.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 event was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to the reported defects ¿stent failed/unable to open¿ and ¿sdw stuck in stent.¿.

• 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
• 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: 17265499
• Report Number: 3008881809-2023-00339
• Device Sequence Number: 14942353
• Product Code: NJE
• UDI-Device Identifier: 07613327382211
• UDI-Public: 07613327382211
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/22/2023

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: M003UZAS30210
• Device Catalogue Number: M003UZAS30210
• Device Lot Number: 23914953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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: ECHELON 10 MICROCATHETER (MEDTRONIC); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Sex: Unknown