MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 4.5MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E45150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

This 1 of 2 reports (1st mdr).

Event Description

It was reported that during c6 aneurysm case.Used stryker catheter to deliver the stent (subject device) to half-deploy, delivered coils and then deployed the stent (subject device) completely.At the same time inserted the last coil with crossing technique but the stent (subject device) got stuck at tip of first catheter used and the coil stuck at tip of catheter.The products could not be withdrawn so the operator used a balloon to get the stent (subject device) and the coil back and prepared to arrange another surgery to do the embolization.Patient was sent back home and waiting for next surgery.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

This 1 of 2 reports (1st mdr).H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added.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 found to be deployed, the stent was found to be deformed, the sdw (stent delivery wire) was found to be intact, and the introducer sheath was not returned.A functional inspection was unable to perform as the returned stent was found to be deployed.The reported event is covered in the device direction 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 advance or pullback through catheter to deploy could not be replicated; however, the analysis results are consistent with the reported event.The reported patient medical or surgical intervention required could not be confirmed during the analysis as the event is patient/procedure related.The device did not meet specifications when received for complaint investigation based on visual inspection.The device was analyzed.The stent was found to be deployed and deformed.It is probable that the deformed stent caused friction during the procedure and reported event.As assignable cause of procedural factors will be assigned to the as reported codes 'stent difficult/unable to advance or pullback through catheter', and as analyzed codes 'stent deformed', 'stent deployed prematurely during use' as the complaint appears to be associated with a product that met stryker design and manufacturing specifications but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause undeterminable will be assigned to the as reported 'patient medical or surgical intervention required' as based on the event description and additional information a definite cause could not be identified.

Event Description

It was reported that during c6 aneurysm case.Used stryker catheter to deliver the stent (subject device) to half-deploy, delivered coils and then deployed the stent (subject device) completely.At the same time inserted the last coil with crossing technique but the stent (subject device) got stuck at tip of first catheter used and the coil stuck at tip of catheter.The products could not be withdrawn so the operator used a balloon to get the stent (subject device) and the coil back and prepared to arrange another surgery to do the embolization.Patient was sent back home and waiting for next surgery.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM 3 EZ 4.5MM 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: 16899819
• MDR Text Key: 314884579
• Report Number: 3008881809-2023-00234
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003EN3E45150
• Device Lot Number: 23857474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• 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: METRONIC COIL (NON-STRYKER); SL-10 CATHETER (STRYKER); TARGET COILS (STRYKER); XT-27 CATHETER (STRYKER)
• Patient Outcome(s): Required Intervention