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

Catalog Number M003EZAS40210

Device Problems Premature Activation (1484); No Visual Prompts/Feedback (4021)

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

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available to manufacturer.

Event Description

It was reported that during the procedure, physician felt resistance while advancing the subject stent within the microcatheter.When the subject stent was advanced to the distal end of the microcatheter to deploy, the physician was unable to see the subject stent under fluoroscopy.The physician tried to deploy the subject stent without identifying the location of the stent.The microcatheter was then removed and it was observed that the subject stent was partially deployed within the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during the procedure, physician felt resistance while advancing the subject stent within the microcatheter.When the subject stent was advanced to the distal end of the microcatheter to deploy, the physician was unable to see the subject stent under fluoroscopy.The physician tried to deploy the subject stent without identifying the location of the stent.The microcatheter was then removed and it was observed that the subject stent was partially deployed within the microcatheter.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 inspection, the stent was noted to be prematurely deployed within the proximal end of the microcatheter shaft and hub.The stent was noted to be extensively deformed with some fractured struts.The introducer sheath and sdw (stent delivery wire) were not returned.During functional test, the stent was removed from the microcatheter.The microcatheter was flushed and blood exited.A patency mandrel experienced friction during advancement through the microcatheter, dried blood was noted on the mandrel when it exited the microcatheter.The patency mandrel passed through the microcatheter without difficulty after the blood was cleared from microcatheter.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 events can be confirmed based on the device analysis.The device failed to meet specification when returned, based on the damage noted.It was reported sharp friction was observed when the stent was passed into the microcatheter, the resistance gave way and when the stent was raised at the distal end of the microcatheter for release, the stent was not visualized.The microcatheter was removed and it was observed that the stent was partially released at the proximal end of the microcatheter.Additional information states that the device was prepared for use as per the directions for use, continuous flush set up and maintained throughout the clinical procedure.The device was returned and the stent was noted to be prematurely deployed within the hub/proximal end of the microcatheter, confirming the reported event.The stent was removed and found to be severely deformed with fracturing to some struts.There was blood noted within the microcatheter which may have caused or contributed to the reported events.It is probable that the stent was prematurely deployed in the proximal end of the microcatheter and the microcatheter hub, during the attempt to transfer the stent into the microcatheter, when the resistance 'gave way' it is probable that the stent delivery wire was then advanced through the microcatheter, leaving the stent prematurely deployed in the proximal end of the microcatheter, hence , why the stent was unable to be visualized under fluoroscopy.An assignable cause of procedural factors will be assigned to the as reported ¿stent deployed prematurely during use¿, ¿ stent difficult/unable to advance or pullback through catheter¿ and ¿ implant not visible under fluoroscopy¿ and to the as analyzed defects, ¿stent deployed prematurely during use¿, ¿stent deformed¿ and ¿stent broken/fractured during use¿, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• 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: 16239406
• MDR Text Key: 308768347
• Report Number: 3008881809-2023-00039
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• 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: 23743105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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: AXS INFINITY LONG SHEATH (STRYKER); EXCELSIOR SL 10 MICROCATHETER (STRYKER); TRANSEND GUIDEWIRE (STRYKER)
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 73 KG