MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30210

Device Problem Fracture (1260)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that during the stent assisted coil embolization for the coil compaction of anterior cerebral artery-distal (a2-a3 bifurcation, physician attempted to deliver the subject stent to the target site using the microcatheter.However, the subject stent broke off from the delivery wire when it entered the anterior cerebral artery.Physician removed the subject stent along with the microcatheter.The subject stent was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿ updated.H3 summary attached - updated.D4 expiration date - added.Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the device returned with microcatheter.The stent was found to be deployed inside the microcatheter.It was removed together with sdw (stent delivery wire) during the analysis of the microcatheter.The sdw was noted to be kinked/bent.There was no breakage noted.The stent was found to be deformed.Dry blood was noted on the stent.The stent introducer sheath was not returned.During functional inspection, stent difficult/unable to transfer functional test was unable to perform as the stent was found to be deployed.Sdw broken/fractured during use was not applicable.It was not confirmed during visual inspection.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 as reported event ¿sdw broken/fractured during use' was not confirmed during inspection.The as reported event ¿stent difficult/unable to transfer' could not be duplicated as the stent was returned deployed inside microcatheter.However, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received from the customer indicates 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 and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was described as 'severely tortuosity'.It was reported that 'an attempt was made to deliver the subject stent to the target site using the subject microcatheter; however, the stent got broken off from the delivery wire when it entered the aca (anterior cerebral artery).It was removed with the entire microcatheter, and the system was replaced with another lot of microcatheter and stent, and the procedure was continued.The stent was probably broken off from the stent delivery wire inside the body.The subject microcatheter which has the stent inside will be returned for the investigation'.The stent was returned for analysis deployed inside microcatheter.The stent was removed from the microcatheter lumen through use of a 0.0158" patency mandrel.Once removed, the stent was inspected and was noted to be damaged in its middle section.All 6 marker bands were present on the stent and there was evidence of dried blood present on the stent.The introducer sheath was not returned for analysis.The stent delivery wire (sdw) was also returned for analysis.The sdw was kinked/bent in multiple locations along its length.It was reported through the follow-up good faith effort process that resistance was felt at the hub of the microcatheter.This suggests that there may have possibly been an issue when initially transferring the stent out of the introducer sheath into the microcatheter lumen.However, there is insufficient additional evidence available to determine if this was the case.An assignable cause of ¿procedural factors¿ has been assigned to the as reported ¿stent difficult/unable to transfer' and to the as analyzed ¿stent deployed prematurely during use¿, ¿stent deformed¿, ¿sdw kinked/bent¿ as this complaint appears to be associated with a product that met the manufacturers design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.As reported ¿sdw broken/fractured during use¿ will be given an assignable cause of ¿not confirmed' as the sdw was returned and was damaged but was not broken.

Event Description

It was reported that during the stent assisted coil embolization for the coil compaction of anterior cerebral artery-distal (a2-a3 bifurcation, physician attempted to deliver the subject stent to the target site using the microcatheter.However, the subject stent broke off from the delivery wire when it entered the anterior cerebral artery.Physician removed the subject stent along with the microcatheter.The subject stent was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM 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: 18155802
• MDR Text Key: 329265100
• Report Number: 3008881809-2023-00552
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 24173719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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)