MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30210

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

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

During the treatment of a ruptured cerebral aneurysm in the posterior inferior cerebellar artery when the subject stent was advanced in the catheter, it could not be seen under fluoroscopy.Upon examination, the subject stent was found deployed in the catheter shaft.The catheter and subject stent were replaced and the procedure was completed successfully with no clinical consequences to the patient.

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 without packaging so the lot number was not confirmed.During visual inspection the stent delivery wire (sdw) was seen to be kinked.The stent was seen to be deformed and the introducer sheath distal tip was seen to be damaged.All 6 marker bands were seen to be present both distal/proximal end of the stent.During the functional inspection to determine if the stent had deployed inside the returned catheter, the catheter was flushed and a 0.0158" patency mandrel was advanced through.There was resistant felt 7cm from the catheter hub, so then the mandrel was advanced distally through the catheter, this time pushing the deployed stent into the catheter hub.The reported stent deployed prematurely during use was confirmed during analysis.The reported ro marker(s) detached/separated/not visible under fluoroscopy was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.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 device was returned for analysis with a catheter.The stent was found to be deployed within the proximal of the catheter shaft.It was removed from the catheter and was found to be deformed.The sdw was returned and found to be kinked.The introducer sheath was returned and was found the distal tip was damaged.Its likely some resistance was felt within the catheter due to the catheter damage noted during analysis while attempting to transfer the stent and manipulation of the device would have caused the damage noted to the stent device and the subsequent stent premature deployment.The as reported event and analyzed damaged of the stent deployed prematurely during use as well as the as analyzed damage of the stent delivery wire (sdw) kinked/bent, stent deformed, stent introducer sheath damaged 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 and/or anatomical factors during use."not confirmed" will be assigned to the reported event of the ro marker(s) detached/separated/not visible under fluoroscopy as all marker bands were found to present on the stent during device analysis.

Event Description

During the treatment of a ruptured cerebral aneurysm in the posterior inferior cerebellar artery when the subject stent was advanced in the catheter, it could not be seen under fluoroscopy.Upon examination, the subject stent was found deployed in the catheter shaft.The catheter and subject stent were replaced and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: NEUROFORM ATLAS 3.0MM 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: 15882770
• MDR Text Key: 306445142
• Report Number: 3008881809-2022-00601
• 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,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 23416460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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: SL-10 CATHETER (STRYKER)