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

Catalog Number M003EZAS30150

Device Problems Entrapment of Device (1212); Difficult or Delayed Activation (2577)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 09/11/2023

Event Type  Death  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during the anterior communicating artery (a-com) aneurysm procedure, the subject stent was deployed using a microcatheter.Although the subject stent was deployed well enough from the second strut, the distal tip of the subject stent was not completely deployed.Due to this, the subject stent delivery wire (sdw) got stuck on its distal tip.The operator attempted to retrieve the subject stent delivery wire but due to severe vascular tortuosity the catheter deviated from the target vessel.When the operator placed the catheter to the target site, the sdw could be pulled out with extreme force causing the hemorrhage which eventually led to the brain-death.The 60 minutes surgical delay was reported.No further information available.

Event Description

It was reported that during the anterior communicating artery (a-com) aneurysm procedure, the subject stent was deployed using a microcatheter.Although the subject stent was deployed well enough from the second strut, the distal tip of the subject stent was not completely deployed.Due to this, the subject stent delivery wire (sdw) got stuck on its distal tip.The operator attempted to retrieve the subject stent delivery wire but due to severe vascular tortuosity the catheter deviated from the target vessel.When the operator placed the catheter to the target site, the sdw could be pulled out with extreme force causing the hemorrhage which eventually led to the brain-death.The 60 minutes surgical delay was reported.No further information available.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not conducted as the device was not returned.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 reported event was unable to be confirmed and it cannot be confirmed if the device met specification, as the product was not returned.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was described as 'very meandering'.In the follow-up questions the physician stated that ' the anatomy and/or location of intended area of treatment may have contributed to the reported event'.They also stated that the subject stent caused the adverse event.It was reported that 'deployment was performed from the microcatheter.Although the stent was deployed well enough from the second strut, the distal tip of the stent was not completely deployed.Because of that, the stent delivery wire became stuck in the distal tip of the stent and could not be pulled out.Therefore, an attempt was made to retrieve the delivery wire by the catheter; however, the vascular tortuosity was so severe that the distal access catheter (dac) seemed to be deviated from the target vessel, the microcatheter was advanced as close as the target site, and the delivery wire could be pulled out under extraordinarily strong resistance, and resulting the hemorrhage.The stent itself was placed as planned; however, it was informed that the patient was in a brain-dead state by the doctor'.The risk of the reported intracranial hemorrhage and patient death is documented in the subject device dfu, as potential adverse events which can occur as a result of these type of procedures.Therefore an assignable cause of anticipated procedural complication, will be assigned to the reported events 'patient intracranial hemorrhage' and 'patient death'.While there are 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 to the reported events 'stent partial deployment' and 'sdw stuck in stent'.

• 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17941338
• MDR Text Key: 325752734
• Report Number: 3008881809-2023-00508
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• 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: 24037223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• 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: DISTAL ACCESS CATHETER (UNKNOWN); EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Outcome(s): Other; Death