MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.0 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40210

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic inspection of the device found that the stent delivery wire (sdw) was kinked at 10cm & 33 cm from the distal end, likely due to handling.The stent was returned in its deployed state and there was some slight deformation noted to the stent.No other anomalies were noted.Functional test could not be performed as the stent was returned deployed.It is possible that stent prematurely deployed outside the patient most likely due to inability to pull back the stent after unsuccessful advancement during the procedure.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 outside the patient.No consequences to the patient were reported.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.0 X 21MM 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: 8215553
• MDR Text Key: 132061907
• Report Number: 3008881809-2019-00007
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Catalogue Number: M003EZAS40210
• Device Lot Number: 20762290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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