MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS30210
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the stent was not visible under fluoroscopy.The procedure was completed with another of the same device and there was no clinical consequence to the patient.
Additional Manufacturer Narrative
Expiration date ¿ added, date of implant ¿ added, device evaluated by mfg ¿updated, summary attached - updated, manufacturing date ¿ added.The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic examination of the returned device found a link on the mid & distal shaft of the stent delivery wire.Functional testing could not be performed as the stent & introducer sheath were not returned.The reported issue is covered in the device directions for use.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 complaint was confirmed based on the information provided and investigation, it is likely that the issue is due to handling of the device during the clinical procedure, removal of the device from the packaging, or preparation of the device prior to use.Based on the available information, a cause of handling damage has been assigned this investigation.
Event or Problem Description
It was reported the stent was not visible under fluoroscopy.The procedure was completed with another of the same device and there was no clinical consequence to the patient.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8605737
• Report Number: 3008881809-2019-00122
• Device Sequence Number: 2948129
• Product Code: NJE
• UDI-Device Identifier: 07613252656159
• UDI-Public: 07613252656159
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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 Expiration Date: 10/31/2023
• Device Catalogue Number: M003SZAS30210
• Device Lot Number: 21009149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1