MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30150

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  Injury  

Event Description

It was reported that during stent assisted coil embolization procedure of internal carotid artery, after coil embolization of the targeted aneurysm, while deployment of the the stent (subject device) to cover the neck of the aneurysm, the stent migrated during deployment while retracting microcatheter in a continuous movement.Due to inability to cover the neck of the aneurysm as expected, resulted in shifting of the coils to distal vessel.The operator had to deploy a atlas stent at distal to press the coil onto the vessel wall and deployed another atlas stent distally at the neck of aneurysm to assist the migrated stent to cover the neck of aneurysm.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

D4: expiration date - added.H4: manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual testing as well as functional testing cannot be performed as the subject device is not available.The reported event is covered in the device directions for use (dfu).As well, 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.The device was not returned for analysis and therefore the as reported cannot be confirmed and while there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.

Event Description

It was reported that during stent assisted coil embolization procedure of internal carotid artery, after coil embolization of the targeted aneurysm, while deployment of the stent (subject device) to cover the neck of the aneurysm, the stent migrated during deployment while retracting microcatheter in a continuous movement.Due to inability to cover the neck of the aneurysm as expected, resulted in shifting of the coils to distal vessel.The operator had to deploy a atlas stent at distal to press the coil onto the vessel wall and deployed another atlas stent distally at the neck of aneurysm to assist the migrated stent to cover the neck of aneurysm.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11211514
• MDR Text Key: 228166024
• Report Number: 3008881809-2021-00044
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30150
• Device Lot Number: 22452633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SL-10 MICRO CATHETER (STRYKER).; SL-10 MICRO CATHETER (STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR