MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40210

Device Problems Fracture (1260); Premature Activation (1484)

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

Event Date 03/29/2023

Event Type  malfunction  

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 inspection, the stent was found to be deployed.The stent was found inside the concurrent microcatheter.The stent delivery wire (sdw) was found to be kinked/bent.The sdw was found to be broken/fractured.The broken off part was found inside the concurrent microcatheter.The stent was found to be deformed.The stent introducer sheath was found to be intact.A functional test for the reported stent difficult/unable to transfer could not be performed as the stent was found to be deployed.The stent introducer sheath was placed into the hub and there were no anomalies noted.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 stent difficult/unable to transfer could not be replicated; however, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on visual inspection.The device was analyzed.The stent was found to be deployed and deformed.The sdw was found to be broken/fractured and kinked.The stent introducer sheath was found to be intact.It is probable that these damages may have caused the reported event during the procedure.An assignable cause of procedural factors will be assigned to the reported defect stent difficult/unable to transfer and analyzed defects sdw kinked/bent, stent prematurely deployed during use, sdw broken/fractured during use and stent deformed 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 it was discovered that the subject stent delivery wire (sdw) was found to be broken/fractured during use and the subject stent was found to be deployed during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 4.0MM 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: 17269332
• MDR Text Key: 318510422
• Report Number: 3008881809-2023-00340
• 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
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS40210
• Device Lot Number: 23972231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• 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: XT-17 MICROCATHETER (STRYKER)