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 Code	Fracture (1260)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, after deploying the subject stent in the m2/m1 vessel the operator tried to re-cross the wire to select the other vessel for the second stent.The guidewire got stuck on to the subject stent.While trying to free the wire, the operator pulled out a portion of the subject stent.The patient¿s m1 vessel appeared to be occluded in the final run.No further information available.
Event or Problem Description
It was reported that during the procedure, after deploying the subject stent in the m2/m1 vessel the operator tried to re-cross the wire to select the other vessel for the second stent.The guidewire got stuck on to the subject stent.While trying to free the wire, the operator pulled out a portion of the subject stent.The patient¿s m1 vessel appeared to be occluded in the final run.Additional information received on 23-june-2023 confirmed that a wide neck aneurysm in the middle cerebral artery (mca) bifurcation was being treated but the procedure was not completed.The physician attempted to remove the broken section of the stent with a snare but was unsuccessful.No further information available.
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 product 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 event.

• 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: 17104766
• Report Number: 3008881809-2023-00294
• Device Sequence Number: 6069979
• Product Code: NJE
• UDI-Device Identifier: 07613327382211
• UDI-Public: 07613327382211
• 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): 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M003UZAS30210
• Device Catalogue Number: M003UZAS30210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 MICROCATHETER (STRYKER); SYNCHRO SELECT GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown