MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 24MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30240

Device Problem Fracture (1260)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

The subject stent was returned for analysis and the device investigation revealed that subject stent delivery wire was broken/fractured during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

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/microscopic inspection, the stent was returned deployed and slightly deformed.The stent delivery wire (sdw) was noted to be kinked/bent.The sdw distal end was noted to be deformed and broken/fractured.The stent introducer sheath distal tip was noted to be damaged.A functional inspection could not be performed as the stent was returned deployed.The sdw could not be removed from the stent introducer sheath during analysis.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 and stent difficult/unable to advance or pullback through catheter was not confirmed during device analysis, however, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on functional and visual inspection.The event description indicated that the subject stent was being used in a stenosis case which is not recommended.The neuroform atlas stent 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 during stent deliver big resistance was encountered in introducing sheath so the operator cut 2mm at tip of sheath and then tried to advance the stent again, but after placing the stent into the microcatheter resistance was still felt and the stent could not advanced any more.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 and analyzed, the stent was returned in the condition of deployed and slightly deformed, however it was reported the stent was deployed by the operator outside of the patient.The sdw-stent delivery wire was returned and found to be kinked, deformed and the wire was also found to be broken and the stent introducer sheath was returned and found to have the distal tip cut, as per the details provided in the event description this cut was made by the operator.Its likely that the damage noted to the device was due to manipulation when the reported resistance was felt during the clinical procedure.The as reported 'stent difficult/unable to transfer' and 'stent difficult/unable to advance or pullback through catheter' as well as the as analyzed 'sdw broken/fractured during use', 'sdw deformed', 'sdw kinked/bent' and 'stent deformed' 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 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: 16031403
• MDR Text Key: 308234747
• Report Number: 3008881809-2022-00646
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30240
• Device Lot Number: 23296460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• 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
• Treatment: 6F GUIDER (STRYKER); SL-10 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); XT-27 MICROCATHETER(STRYKER)
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Race: Asian