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

Catalog Number M003EZAS40240

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

It was reported that during one posterior communicating artery (pcoma) aneurysm procedure the-operator used the microcatheter to deliver the subject stent to the lesion.Operator withdrew the subject stent and the microcatheter together to release the tension and position.While deploying the subject stent when the distal marker was expanded, the microcatheter and subject stent migrated downward.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during one posterior communicating artery (pcoma) aneurysm procedure the-operator used the microcatheter to deliver the subject stent to the lesion.Operator withdrew the subject stent and the microcatheter together to release the tension and position.While deploying the subject stent when the distal marker was expanded, the microcatheter and subject stent migrated downward.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

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.During visual inspection it was noted that the device was returned together with the microcatheter.The stent was found to be partially deployed.The dry blood and procedural fluids were noted on the stent delivery wire (sdw).The stent was found to be deformed.The distal part of the sdw was found to be kinked/bent.The stent introducer sheath was not returned.Functional inspection to test the reported event ¿stent partial deployment¿ was not performed as it was confirmed during visual inspection.Functional inspection to test the reported event ¿unexpected movement of device¿ was not performed as the event can¿t be duplicated.The device was flushed, and the stent was deployed on the table without difficulties.The reported event is covered in the device direction 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 'stent partial deployment' was visually confirmed as the stent was returned for analysis partially deployed from the distal opening of the microcatheter.The reported event 'unexpected movement of device' could not be duplicated as this is a procedure-related issue.However, the analysis results are consistent with the reported event.The returned device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted.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 'moderately tortuous'.It was reported that 'the operator used the microcatheter 150cm 2 tip to deliver the subject stent to the lesion.Then the operator withdrew the subject stent and microcatheter out together to release the tension and position, and after the subject stent was deployed for a few mm, the distal marker was expanded and then the microcatheter and the subject stent suddenly migrated downward.The operator withdrew the whole system and used a new microcatheter and new stent to continue the procedure to finish'.This indicates that the operator was in the act of deploying the stent when the unexpected movement of the microcatheter and stent occurred.The stent was returned for analysis partially deployed from the distal opening of the microcatheter.There were some dried procedural fluids present and the sdw was kinked at the point where it exited the microcatheter distal opening.The system was flushed and the stent was fully advanced from the microcatheter distally.The stent was inspected and noted to be damaged towards the distal (open cell) end and also in it's middle section.The sdw was fully removed from the microcatheter and was only kinked in it's distal section.The introducer sheath was not returned for analysis.An assignable cause of procedural factors has been assigned to the reported events ¿unexpected movement of device' and 'stent partial deployment¿ and to the analysed events ¿stent partial deployment¿, ¿sdw kinked/bent¿, ¿stent deformed¿ 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.

• 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: 18341539
• MDR Text Key: 330679557
• Report Number: 3008881809-2023-00586
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2023
• 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: 23687844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Race: Asian