MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS40240
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent delivery wire became stuck inside the deployed stent (subject device) along with the guidewire and microcatheter.The physician removed all three devices and completed the procedure successfully without clinical consequences to the patient.
Event or Problem Description
It was reported that the stent delivery wire became stuck inside the deployed stent (subject device) along with the guidewire and microcatheter.The physician removed all three devices and completed the procedure successfully without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The stent delivery wire(sdw) was returned within the microcatheter used during the procedure.Visual and microscopic inspection of the device found that there was no stent or introducer sheath returned.No other anomalies were noted.During functional test, sdw was unable to be advanced to the distal end of the microcatheter.The sdw was removed from the microcatheter; and procedural fluid was noted on the sdw.The microcatheter was flushed and procedural fluid exited the catheter.The sdw was noted to be bent at 15cm from the distal tip as well.Information available indicated that the device was confirmed to be in good condition prior to use, device was prepared as per the dfu and the procedural fluid noted within the microcatheter indicated that insufficient flush contributed to the event, but cannot be definitively determined.The returned microcatheter used with stent was found to be flattened at the distal end, which is likely to have caused the as reported and observed damages noted to the sdw.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM 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: 7748437
• Report Number: 3008881809-2018-00331
• Device Sequence Number: 1258334
• Product Code: NJE
• UDI-Device Identifier: 07613252656203
• UDI-Public: 07613252656203
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/25/2018

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: 03/12/2023
• Device Catalogue Number: M003SZAS40240
• Device Lot Number: 20397577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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: EXCELSIOR MICROCATHETER(STRYKER); SYNCHRO GUIDEWIRE(STRYKER)