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 03/21/2023

Event Type  malfunction  

Event Description

The subject stent was returned for analysis and it was discovered that the stent was broken/ fractured during use and the stent delivery wire (sdw) was broken/fractured during use.No clinical consequences were reported to the patient due to this event.The physician replaced it with a new device and successfully completed the procedure.

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 the visual inspection, the stent was seen to be deployed and broken.The stent delivery wire (sdw) was seen to be kinked.The sdw was seen to be broken with part of the broken wire was stuck through the broken stent.The stent introducer sheath was seen to be missing the distal tip (reported the tip was cut by the operator).The device was returned with a microcatheter hub and a little bit of the catheter shaft, a mandrel was advanced through the cut section of the catheter shaft to push out part of the deployed broken stent and broken sdw through the catheter hub.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 and stent difficult/unable to transfer could not be replicated 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.The event description indicated that the stent was being used in a stenosis case which is not recommended.The dfu states "the neuroform atlas stent system is intended to be used with occlusive devices in the treatment of intracranial aneurysms".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.Part of the stent was returned broken and deployed, with the other segment of the broken deployed stent inside a section of a microcatheter.The stent segment that was inside the catheter was removed and was found that a broken segment of the sdw was stuck through the stent.The introducer sheath was returned and was found to be cut at the distal tip, however it was reported this cut was made by the operator, therefore a code will not be assigned for this sheath damage to this complaint.Its likely when the reported resistance was felt while attempting to transfer the device into the catheter during the procedure manipulation of the device would have caused the damage noted during analysis.The reported events stent difficult/unable to advance or pullback through catheter and stent difficult/unable to transfer as well as the analyzed defects stent deployed prematurely during retraction/re-sheathing, sdw broken/fractured during use, stent broken/fractured during use and sdw kinked/bent 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.

• 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: 17004868
• MDR Text Key: 316026189
• Report Number: 3008881809-2023-00270
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• 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: 23757136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); GATEWAY BALLOON (STRYKER); GUIDER GUIDE CATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: Asian