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

Catalog Number M003EZAS30150

Device Problems Break (1069); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The device history record review confirms that the device met all material, assembly and performance specifications.The stent was returned with the stryker microcatheter used during the procedure.Visual and microscopic inspection of the device found that the stent delivery wire (sdw) was broken at the distal bumper and the stent was found to be deployed inside the microcatheter hub along with the distal section of the sdw.The stent was noted to be deformed as well.Functional test could not be performed due to the damaged condition of the returned device.The stent was returned prematurely deployed within the stryker xt-17 microcatheter hub.It is likely that procedural factors contributed to the reported and 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 Description

Analysis of the returned device noted that the stent had prematurely deployed during use and the stent delivery wire (sdw) was found broken.No consequences to the patient were reported.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 15MM WITHOUT TIP
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8609245
• MDR Text Key: 145018043
• Report Number: 3008881809-2019-00125
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H020002/S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: M003EZAS30150
• Device Lot Number: 19611386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: XT-17 MICROCATHETER (STRYKER)