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 Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that during the procedure, the subject stent ro marker came loose and migrated.There were no clinical consequences to the patient reported due to this event.No additional information was provided.
Additional Manufacturer Narrative
B5: executive summary ¿ updated.F10 / h6: clinical signs code grid ¿ updated.Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional testing could not be performed since the device was implanted in the patient.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.While there are a number of potential causes for the reported event, as the device was not returned and the available information fails to indicate a cause or probable cause for the reported event, an assignable cause of undeterminable will be assigned to the as reported issues ro marker(s) detached/not visible under fluoroscopy and un-retrieved device fragments.
Event or Problem Description
It was reported that during the procedure, the subject stent ro marker came loose and migrated.There were no clinical consequences to the patient reported due to this event.No additional information was provided.Additional information received on (b)(6) 2020 indicated that the subject stent was implanted in the left m2 and just the ro marker of the stent detached and migrated away from the target site.The ro marker was left inside the patient vasculature.No medical intervention was performed due to this event.

• 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
• MDR Report Key: 10480791
• Report Number: 3008881809-2020-00251
• Device Sequence Number: 2815970
• Product Code: NJE
• UDI-Device Identifier: 07613327382129
• UDI-Public: 07613327382129
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 11/06/2020

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: M003UZAS45300
• Device Catalogue Number: M003UZAS45300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1