MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP- HDE; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003SZAS30210
Medical Device Problem Codes	Fracture (1260); Premature Activation (1484)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during the procedure, the physician tried to resheath the stent (subject device), a piece of the distal stent (subject device) broke off and was deployed, the other part of the stent (subject device) was removed from the patient in the microcatheter.The other distal part of the stent tines (subject device) were left in the patient and covered with the second stent.Based on physicians opinion, resheathing was caused the stent (subject device) to be fractured.No other information was provided.
Additional Manufacturer Narrative
The device history record review confirms that there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported events are covered in the device directions for use (dfu).The risks of the reported events are documented in the risk analysis and there are current controls to mitigate the risks of the as reported events.The device was confirmed to be in a good condition prior to use.The event description states that the event occurred when the physician attempted to re-sheathed the stent however, neuroform atlas is not intended for this type of use.The atlas stent is not re-sheathable.An assignable cause of user error will be assigned to the as reported as the investigation confirms that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
It was reported that during the procedure, the physician tried to resheath the stent (subject device), a piece of the distal stent (subject device) broke off and was deployed, the other part of the stent (subject device) was removed from the patient in the microcatheter.The other distal part of the stent tines (subject device) were left in the patient and covered with the second stent.Based on physician¿s opinion, resheathing was caused the stent (subject device) to be fractured.No other information was provided.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM NO TIP- HDE
• 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: 11935743
• Report Number: 3008881809-2021-00221
• Device Sequence Number: 4381270
• Product Code: NJE
• UDI-Device Identifier: 07613252656159
• UDI-Public: 07613252656159
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• 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): 09/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: M003SZAS30210
• Device Catalogue Number: M003SZAS30210
• Device Lot Number: 21260765
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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: HEADADWAY 17 MICROCATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention