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

Catalog Number M003EZAS40240

Device Problem Premature Activation (1484)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported that during an endovascular procedure in a patient, the subject stent could not be advanced any more after it was advanced from introducing sheath to go into microcatheter.The subject stent got stuck in microcatheter.When the operator tried to withdraw the stent, only the stent delivery wire was taken out.The operator cut the microcatheter and found the subject stent was left inside the microcatheter.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

The device is not available to the manufacturer.

Manufacturer Narrative

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 atlas device was returned with a cut stryker catheter (reported this cut was made by the operator to locate the stent).The deployed stent was seen to be deployed and protruding from part of the cut catheter shaft.The stent delivery wire (sdw) was seen to be kinked.The stent was seen to be deformed.The introducer sheath distal tip was seen to be damaged.During functional inspection, the deployed stent was removed from the catheter shaft for further analysis.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 stent deployed prematurely during use was confirmed during analysis.The reported stent difficult/unable to advance or pullback through catheter could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Addition information received was the device was prepared 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 prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The device was returned for analysis with a fractured stryker catheter, it was reported the catheter was cut by the operator to locate the deployed stent.The stent was found to be deployed and protruding from the proximal of the catheter shaft, it was removed from the catheter during analysis and was found to be deformed.The sdw was returned and found to be kinked.The introducer sheath was returned and was found the distal tip was damaged.Its likely when the reported resistance was felt while attempting to transfer the device through the catheter manipulation of the device would have caused the damage noted and the subsequent premature deployment.The as reported events of 'stent deployed prematurely during use' and 'stent difficult/unable to advance or pullback through catheter' as well as analyzed events of 'stent deployed prematurely during use', 'sdw kinked/bent', 'stent deformed' and 'stent introducer sheath damaged' will be assigned procedural factors as this complaint appears to be associated with a product that met stryker 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.

Event Description

It was reported that during an endovascular procedure in a patient, the subject stent could not be advanced any more after it was advanced from introducing sheath to go into microcatheter.The subject stent got stuck in microcatheter.When the operator tried to withdraw the stent, only the stent delivery wire was taken out.The operator cut the microcatheter and found the subject stent was left inside the microcatheter.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.

• 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: 16031402
• MDR Text Key: 308148679
• Report Number: 3008881809-2022-00645
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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: 23182417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2021
• 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: XT-17 MICROCATHETER (STRYKER)
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: Asian