MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 3.0MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E30150

Device Problem Premature Activation (1484)

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

Event Date 10/18/2022

Event Type  malfunction  

Event Description

It was reported that during ica supraclinoid segment dissection case, the operator used catheter to deliver stent (subject device).After the stent (subject device) was placed to the location, the operator found the position of the delivery catheter was not proper so tried to withdraw the stent (subject device) back to introducing sheath, but it could not be retracted to sheath even with more force to try.Finally the operator withdrew the sheath and then used big force to retract the delivery wire and found the stent (subject device) deployed unexpectedly and half of the stent was in catheter and the other half was in hub.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

The device is not available to the manufacturer.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the stent was returned deployed in the hub of a microcatheter, the sdw (stent delivery wire) distal tip was noted to be kinked/bent, the introducer sheath distal tip was noted to be damaged, and the stent was noted to be deformed.A functional test could not be performed as the stent was deployed.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 stent difficult/unable to pull stent back into sheath and sdw friction could not be confirmed; however, the analysis results are consistent with the reported event.The reported event stent deployed prematurely during use was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Addition 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 the concurrent xt-27 microcatheter complaint.The stent was returned deployed within the proximal shaft and hub of the catheter confirming the reported premature deployment.The stent was found to be deformed once removed from the catheter.The sdw (stent delivery wire) was returned and found to be kinked.The introducer sheath was returned and was found the distal tip was damaged.Its likely manipulation would have caused the damage noted to the device and the subsequent premature deployment.The as analyzed 'stent deployed prematurely during use', 'stent deformed', 'sdw kinked/bent', 'stent introducer sheath damaged', as well as the as reported codes 'stent deployed prematurely during use', 'sdw friction' and 'stent difficult/unable to pull stent back into sheath' 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.

Event Description

It was reported that during ica supraclinoid segment dissection case, the operator used catheter to deliver stent (subject device).After the stent (subject device) was placed to the location, the operator found the position of the delivery catheter was not proper so tried to withdraw the stent (subject device) back to introducing sheath, but it could not be retracted to sheath even with more force to try.Finally the operator withdrew the sheath and then used big force to retract the delivery wire and found the stent (subject device) deployed unexpectedly and half of the stent was in catheter and the other half was in hub.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: NEUROFORM 3 EZ 3.0MM X 15MM - 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: 15711000
• MDR Text Key: 307062183
• Report Number: 3008881809-2022-00543
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H020002/S046
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EN3E30150
• Device Lot Number: 23500887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2022
• 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: SYNCHRO GUIDEWIRE (STRYKER); XT-27 CATHETER (STRYKER)
• Patient Race: Asian