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	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during advancement of the stent (subject device) through a microcatheter, the stent prematurely disconnected from the delivery wire within the microcatheter.The stent and microcatheter were removed as one unit.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during advancement of the stent (subject device) through a microcatheter, the stent prematurely disconnected from the delivery wire within the microcatheter.The stent and microcatheter were removed as one unit.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.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.Information available indicated that the device was confirmed to be in good condition prior to use.It is probable that there were some procedural/anatomical factors that contributed to the event; this however cannot be conclusively determined.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.

• 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: 8567575
• Report Number: 3008881809-2019-00114
• Device Sequence Number: 14026641
• Product Code: NJE
• UDI-Device Identifier: 07613252656159
• UDI-Public: 07613252656159
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/03/2019

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: 12/04/2023
• Device Catalogue Number: M003SZAS30210
• Device Lot Number: 21069100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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: XT-17 MICROCATHETER (STRYKER)
• Patient Age: 52 YR