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

Catalog Number M003EZAS40240

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The stent was returned with the microcathether used in procedure and was deployed and jammed inside the catheter hub.Visual and microscopic inspection of the device noted the stent delivery wire (sdw) was deformed, broken, and protruding from the introducer sheath.Damage was also noted to the introducer sheath.The stent could not be advanced for inspection and functional testing could not be performed due to the condition of the returned device.Information reported by the facility indicated that during the transfer of the stent into the hub of the microcatheter, the stent became stuck.Also, information available indicated that both the stent and microcatheter were inspected and confirmed to be in good condition prior to use.Based on the information available and investigation results, it is likely the stent deformed during the transfer into the hub of the microcatheter, resulting in the sdw break and subsequently limiting its performance.Therefore, an assignable cause of operational context was assigned to this investigation.

Event Description

Analysis of the returned device found that the stent delivery wire was broken.There was no patient involvement.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM 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: 7184655
• MDR Text Key: 97064779
• Report Number: 3008881809-2018-00032
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: H020002
• 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: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: M003EZAS40240
• Device Lot Number: 18903417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2016
• 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
• Patient Age: 66 YR