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

Catalog Number M003EZAS40240

Device Problem Fracture (1260)

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

Event Date 12/12/2023

Event Type  malfunction  

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 the stent was found to be stuck in the proximal end of the microcatheter.The stent was released from the proximal end of the microcatheter in analysis and found to be deformed.The stent was found to be broken/fractured.There was tubing of unknown origin wrapped around the middle of the stent which was constricting the stent and preventing it from full deployment even after it had been removed from the microcatheter.The introducer sheath distal tip was found to be damaged.The microcatheter was returned with the device.The stent delivery wire (sdw) was not returned.During functional inspection, a mandrel 0.0158 was advanced through the distal end of the microcatheter.As the mandrel advanced to the proximal end of the microcatheter a blockage was felt.The microcatheter was cut where the blockage was felt during analysis, and the stent was found to be stuck.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 of the stent difficult/unable to advance or pullback through catheter was confirmed during visual inspection.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared as per the dfu.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.It was reported that the 'during the preparation, they followed the standard procedure, while advancing the stent to the catheter they felt a resistance and cannot advanced.They removed the device and completed the procedure with another of the same device'.The reported and analyzed event of the stent difficult/unable to advance or pullback through catheter as well as the as analyzed damage of the stent introducer sheath distal tip damage, stent deformed and stent broken/fractured during use 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 factors during use.

Event Description

The device was returned for analysis and the investigation of the device revealed that the stent (subject device) was found broken/fractured inside the catheter.The procedure was completed successfully.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: 18857589
• MDR Text Key: 337206724
• Report Number: 3008881809-2024-00096
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: 23959299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• 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: SL-10 CATHETER (STRYKER)
• Patient Sex: Male