MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 15MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS30150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject stent was being advanced inside the microcatheter when the entire microcatheter collapsed into the carotid artery causing the subject stent to slip further into the microcatheter.Once the catheter and stent were removed from the patient¿s anatomy, the stent could not be re-sheathed and the stent was prematurely deployed inside the microcatheter.No patient consequences were reported due to this event.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the stent was noted to be deployed in the hub of the microcatheter.No anomalies were noted to the microcatheter.During functional testing, the microcatheter was unable to be flushed, the sent was difficult to remove from the hub and the proximal end of the stent was damage during removal.In case of this complaint, the additional information indicated that the patient¿s anatomy was tortuous and there was solidified blood within the microcatheter which may have causes or contributed to the reported event.It is probable that the initial movement of the microcatheter to cause the unexpected movement of the stent and also it is probable that the blood noted in the microcatheter may have caused or contributed to the difficult to re-sheath the stent and the premature deployment of the sheath in the hub of the microcatheter; therefore, an assignable cause of procedural factors was assigned to the as reported event stent deployed prematurely during use, as this issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the direction for use (dfu) but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the procedure, the subject stent was being advanced inside the microcatheter when the entire microcatheter collapsed into the carotid artery causing the subject stent to slip further into the microcatheter.Once the catheter and stent were removed from the patient¿s anatomy, the stent could not be re-sheathed and the stent was prematurely deployed inside the microcatheter.No patient consequences were reported due to this event.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 15MM 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: 8737474
• Report Number: 3008881809-2019-00183
• Device Sequence Number: 16787232
• Product Code: NJE
• UDI-Device Identifier: 07613252656142
• UDI-Public: 07613252656142
• 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): 08/30/2019

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: 12/09/2023
• Device Catalogue Number: M003SZAS30150
• Device Lot Number: 21083980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 68 YR