MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 21MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003UZAS45210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that during the procedure, the subject stent advanced over the wire and the stent dislodge from the delivery system midway in the microcatheter before it was placed in the target site.The delivery system had to be pulled back over the wire by pulling the dislodged stent along until it was removed from the microcatheter.The stent was successfully removed from the patient¿s anatomy.The subject stent was also reported to be prematurely deployed outside the patient in the tuohy borst valve during removal from the microcatheter.No patient harm was reported due to this event.A medwatch (mw5097311) was received on 03-november-2020 indicating that the event caused unknown serious injury and as a result unknown medical intervention was performed.No additional information was provided.
Additional Manufacturer Narrative
Although the lot number was not provided, the automated manufacturing execution system (mes) has 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 not returned for investigation.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 device was not returned and although the as reported issues cannot be confirmed based on analysis, the as reported event can be confirmed based on the event description.The as reported issues stent migration inside microcatheter, and stent deployed prematurely during retraction/ re-sheathing will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.The as reported issue patient medical or surgical intervention required will be assigned anticipated procedural complication.
Event or Problem Description
It was reported that during the procedure, the subject stent advanced over the wire and the stent dislodge from the delivery system midway in the microcatheter before it was placed in the target site.The delivery system had to be pulled back over the wire by pulling the dislodged stent along until it was removed from the microcatheter.The stent was successfully removed from the patient¿s anatomy.The subject stent was also reported to be prematurely deployed outside the patient in the tuohy borst valve during removal from the microcatheter.No patient harm was reported due to this event.A medwatch (mw5097311) was received on 03-november-2020 indicating that the event caused unknown serious injury and as a result unknown medical intervention was performed.No additional information was provided.

• Brand Name: NEUROFORM ATLAS 4.5MM 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
• MDR Report Key: 10926023
• Report Number: 3008881809-2020-00370
• Device Sequence Number: 11120146
• Product Code: NJE
• UDI-Device Identifier: 07613327382150
• UDI-Public: 07613327382150
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: M003UZAS45210
• Device Catalogue Number: M003UZAS45210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 01/09/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN); MICROCATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention