MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 24MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40240

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 01/03/2022

Event Type  malfunction  

Event Description

It was reported that during the left posterior communicating artery aneurysm procedure, the guidewire was used to bring the microcatheter to the left middle cerebral artery.While deploying the subject stent, the physician withdrew the catheter, but the catheter was not fixed properly and moved unexpectedly with the manipulation which caused the subject stent to be shift.The tip of the subject stent was already deployed when shifted with the microcatheter.The physician retracted the subject stent system together with the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

The device is not available to the manufacturer.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the returned stent was found to be deployed as per the event description.The stent delivery wire (sdw) was found to be kinked.The stent was found to be deformed and there was no introducer sheath returned.Functional inspection cannot be carried out as the stent was returned deployed.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.It was reported that when the stent was placed to the lesion to deploy, the operator withdrew the catheter but the catheter migrated and then the stent shifted(tip of the stent was already deployed).As per the additional information, the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.The microcatheter didn't fix properly and then moved with the manipulation and when the microcatheter moved, the stent moved together.The device was returned and the stent was noted to be deformed and the stent deliver wire (sdw) was kinked.It is probable that the sdw and the stent were damaged by the interaction with the microcatheter.An assignable cause of caused by other will be assigned to the as reported 'stent dislodged/migrated' and 'device interaction with another device' and the as analyzed 'sdw kinked/bent' and 'stent deformed', as the investigation indicates another product/drug/subsequent procedure caused the issue event.

Event Description

It was reported that during the left posterior communicating artery aneurysm procedure, the guidewire was used to bring the microcatheter to the left middle cerebral artery.While deploying the subject stent, the physician withdrew the catheter, but the catheter was not fixed properly and moved unexpectedly with the manipulation which caused the subject stent to be shift.The tip of the subject stent was already deployed when shifted with the microcatheter.The physician retracted the subject stent system together with the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: NEUROFORM ATLAS 4.0MM X 24MM 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: 13419377
• MDR Text Key: 286949739
• Report Number: 3008881809-2022-00044
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS40240
• Device Lot Number: 22510738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET DETACHABLE COIL (STRYKER)
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Race: Asian