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 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during an unruptured aneurysm embolization procedure, the physician inserted the subject stent into the microcatheter.The subject stent was fractured from the delivery wire at around between first and second marker of the microcatheter.The subject stent could not be pulled out, so the physician removed it along with the microcatheter.The subject stent was replaced, and 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.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications, because the product was not returned.Additional information received from the customer indicates that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.It was reported that 'during coil embolization of an unruptured aneurysm, when an attempt was made to place the subject stent, the stent was inserted into a microcatheter; however, the stent was fractured from the delivery wire at around between first and second marker of the microcatheter, and the stent could not be pulled out.Therefore, the entire microcatheter was removed, and a new stent in the same catalog number was inserted in the same microcatheter, and the procedure was completed successfully'.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of ¿undeterminable¿ will be assigned to as reported ¿sdw broken/fractured during use¿.

Event Description

It was reported that during an unruptured aneurysm embolization procedure, the physician inserted the subject stent into the microcatheter.The subject stent was fractured from the delivery wire at around between first and second marker of the microcatheter.The subject stent could not be pulled out, so the physician removed it along with the microcatheter.The subject stent was replaced, and the procedure was completed successfully.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: 18367236
• MDR Text Key: 331068059
• Report Number: 3008881809-2023-00593
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 24218731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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)