MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30150

Device Problem Fracture (1260)

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

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned within a catheter.The lot number was not confirmed as the packaging was not returned with the device.During visual inspection the stent was advanced through the returned catheter.The stent delivery wire (sdw) was seen to be kinked and the stent was seen to be deformed.The introducer sheath was not returned.During the functional inspection, the stent would not advance out of the catheter.The device was then retracted from the catheter where only part of a broken stent retracted out with the sdw.The catheter was then flushed and a patency mandrel was advanced through the catheter pushing out the other section of the broken stent through the tip of the catheter.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 difficult/unable to advance or pullback through catheter was confirmed during device analysis; 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.Additional 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 stent device was returned for analysis with an catheter.The stent system was returned advanced through the returned catheter and could not be advanced out of the catheter during analysis confirming the reported event.The device was then retracted from the catheter during analysis where it was found the stent was broken and deformed.The sdw was returned and found to be kinked and the introducer sheath was not returned for device analysis.Its likely when the reported resistance was felt while attempting to transfer the stent through the catheter during the procedure manipulation of the device would have caused the damage noted to the device during analysis.The as reported event of the stent difficult/unable to advance or pullback through catheter as well as the as analyzed damage of sdw kinked/bent, stent deformed, stent difficult/unable to advance or pullback through catheter 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 broken during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM 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: 17101791
• MDR Text Key: 317137603
• Report Number: 3008881809-2023-00293
• 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
• Report Date: 06/09/2023

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: M003EZAS30150
• Device Lot Number: 23376083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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