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

Catalog Number M003EZAS30150

Device Problem Material Too Soft/Flexible (4007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

This is the first of 2 reports.Subject device remains implanted.

Event Description

It was reported that during stent-assisted coiling of an aneurysm located at the left posterior cerebral at basilar, the subject stent was properly implanted at desired place.When packing the aneurysm sac with coils through a microcatheter, the microcatheter expelled, generating loops of coils between the meshes of the stent.It was confirmed that recanalization was a consequence of the extrusion.There were no clinical consequences to the patient.

Manufacturer Narrative

D4: expiration date: updated.H4: manufacturing date: updated.Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event could not be confirmed; the reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.As per the available information, the subject stent was properly implanted at desired place.When packing the aneurysmal sac, the microcatheter has been expelled, generating loops of coils between the meshes of atlas stent.As the investigation indicates that the subject stent performed as intended and that another product caused the issue event,, an assignable cause of caused by other will be assigned to this complaint.

Event Description

It was reported that during stent-assisted coiling of an aneurysm located at the left posterior cerebral at basilar, the subject stent was properly implanted at desired place.When packing the aneurysm sac with coils through a microcatheter, the microcatheter expelled, generating loops of coils between the meshes of the stent.It was confirmed that recanalization was a consequence of the extrusion.There were no clinical consequences to the patient.

• 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 ; IE NA
• MDR Report Key: 9618122
• MDR Text Key: 176100438
• Report Number: 3008881809-2020-00014
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: M003EZAS30150
• Device Lot Number: 19248216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXELSIOR SL-10 MICORCATHETER (STRYKER).; TARGET COILS (STRYKER).
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR