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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was returned within the stryker microcatheter used during the procedure.Visual inspection of the device revealed that the stent delivery wire (sdw) was protruding from the catheter hub and was broken.The introducer sheath was damaged and the stent could not be retrieved from the microcatheter shaft.Functional testing could not be performed due to the condition of the returned device.Information available indicated that the device was confirmed to be in good condition prior to use and there was no indication of a use error.It is likely that procedural factors contributed to the observed damages limiting the performance of the stent during the clinical procedure.Therefore, an assignable cause of component failure has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device noted that the stent delivery wire (sdw) was broken.No consequences to the patient were reported.

• 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: 8131754
• Report Number: 3008881809-2018-00512
• Device Sequence Number: 243751
• Product Code: NJE
• UDI-Device Identifier: 07613252656159
• UDI-Public: 07613252656159
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 12/04/2018

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: 03/24/2023
• Device Catalogue Number: M003SZAS30210
• Device Lot Number: 20423704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1