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

Catalog Number M003EZAS40210

Device Problem Fracture (1260)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

It was reported that during a case subject stent was used along with microcatheter and resistance was felt while advancing the subject stent within the microcatheter.The procedure was completed successfully with another device.No clinical consequences were reported to the patient due to this event.The subject stent was returned for analysis and the device investigation revealed that the subject stent was found to be broken/fractured during use.

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 and microscopic inspection, it was observed that the subject stent and the stent delivery wire (sdw) were returned within the introducer sheath and there was evidence of stent deformation.There was also evidence of blood.The deployed stent was noted to be broken/fractured and deformed; the remainder of the stent was not returned.There was no damage noted to the sdw or the introducer sheath.Functional testing revealed that the introducer sheath was flushed and the sdw was advanced to deploy the stent and friction was 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 event was not duplicated.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 it.Additional information did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no indication of a user related issue.The sdw and stent were returned within the introducer sheath.There was evidence of blood throughout the returned device.The deployed stent was noted to be broken/fractured and deformed and the remainder of the stent was not returned.There was no damage noted to the sdw or the introducer sheath.The event description indicates there was resistance while advancing the device within the micro catheter.It is most likely that due to unknown procedural or anatomical factors the user experienced resistance while inserting the device though the microcatheter and due to this resistance, the user applied force to try and advance the device through the microcatheter resulting in the deformed and broken stent.The as reported code stent difficult/unable to advance or pullback through catheter and the as analysed defect codes stent deformed, stent broken/fractured during used and sdw friction will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was reported to have been used in accordance with the dfu, but performance was limited due to procedural factors during use.

• 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: 18595183
• MDR Text Key: 333963490
• Report Number: 3008881809-2024-00032
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• 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: 21989976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• 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: 59 YR
• Patient Sex: Female