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

Catalog Number M003EZAS40210

Device Problem No Visual Prompts/Feedback (4021)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during one aneurysm embolization case at mca (middle cerebral artery), the operator could not observe the stent (subject device) under x-ray, withdrew the delivery wire and found the stent (subject device) was left in introducing sheath.The operator replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the stent was found to be deployed inside the stent introducer sheath, the stent was found to be intact.All implant radiopaque markers were found to be present, the sdw (stent delivery wire) was found to be kinked/bent, and the stent introducer sheath found to be intact.During a functional test, the reported stent deployed prematurely during transfer was confirmed during the analysis and the reported implant not visible under fluoroscopy was not confirmed as the stent never entered the patient.The device did not 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.It was reported that the operator could not observe the stent under x-ray, so withdrew the delivery wire and found the stent was left in introducing sheath but not at tip of delivery wire.Additional information received from the customer indicated that the stent did not enter into the body at all but remained in the introducing sheath.The device was returned for analysis and the stent was confirmed to have been prematurely deployed within the introducer sheath and the sdw was kinked.The analysis results are consistent with the reported event.It is probable that the stent was prematurely deployed within the sheath prior to transfer and the sdw was advanced through the microcatheter without the loaded stent, therefore the physician was unable to visualize the stent under fluoroscopy.An assignable cause of procedural factors will be assigned to the reported and analyzed 'stent deployed prematurely during transfer', and to the analyzed 'sdw kinked/bent', 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.An assignable cause not confirmed will be assigned to the reported ¿implant not visible under fluoroscopy', as the information provided, and the analysis confirms that the stent was deployed within the introducer sheath and never entered the patient¿s body.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that during one aneurysm embolization case at mca (middle cerebral artery), the operator could not observe the stent (subject device) under x-ray, withdrew the delivery wire and found the stent (subject device) was left in introducing sheath.The operator replaced it with a new device and continued the procedure without clinical consequences to the patient.

• 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: 15547685
• MDR Text Key: 306278319
• Report Number: 3008881809-2022-00484
• 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,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• 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: 22888367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2021
• 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: NEUROFORM EZ STENT (STRYKER).; SL 10 CATHETER (STRYKER).; XT-27 CATHETER (STRYKER).
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: Asian