MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 3.5MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E35200

Device Problem Fracture (1260)

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

Event Date 11/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during stent assisted aneurysm embolization case.After framed by a first coil the operator prepared to half -deploy the stent (subject device).The operator cut tip of the delivery wire before delivered it (for better manipulation) and then placed the stent (subject device) to half-deploy.However under the dsa (digital subtraction angiography) the operator could not see the tip marker of the stent (subject device).Withdrew the microcatheter and then the distal marker was not able to be seen either.The coil was also migrated out of aneurysm lumen.The operator replaced the stent (subject device) with a new device and continued the procedure without clinical consequences to the patient.

Event Description

It was reported that during stent assisted aneurysm embolization case.After framed by a first coil the operator prepared to half -deploy the stent (subject device).The operator cut tip of the delivery wire before delivered it (for better manipulation) and then placed the stent (subject device) to half-deploy.However under the dsa (digital subtraction angiography) the operator could not see the tip marker of the stent (subject device).Withdrew the microcatheter and then the distal marker was not able to be seen either.The coil was also migrated out of aneurysm lumen.The operator replaced the stent (subject device) with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.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 and was not returned.The sdw (stent delivery wire) was found to be severely kinked/bent in multiply areas.The tip of the sdw was found to be broken/fractured approx.1 cm form the distal bumper.The stent introducer sheath was found to be intact.A functional inspection was not performed as the stent was found deployed and was not returned.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 as reported codes 'ro marker(s) detached/separated/not visible under fluoroscopy' and 'missing/incorrect device/component' were unable to be confirmed because the stent was not returned for analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies reported for the device.Additional information provided by the customer indicated that during device set-up the device was not prepared as per the dfu.The user 'didn't check the stent and cut the introducing sheath'.There was no damage noted to the packaging prior to opening the packaging.However, the device was not 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 the user 'placed microcatheter to go into aneurysm and placed the catheter for stenting.After framed by a first coil the operator prepared to half -deploy the subject stent.The operator cut tip of the delivery wire before delivered it (for better manipulation) and then placed the stent to half-deploy.However under the dsa (digital subtraction angiography) the operator could not see the tip marker of the stent.Withdrew the microcatheter and then the distal marker was not able to be seen either.The coil was also migrated out of aneurysm lumen.The operator felt the stent was not in the system during manufacturing but he didn't check it during preparation.Withdrew the system and used a non-stryker stent to go through the same microcatheter finish the procedure'.The stent was not returned for analysis.The introducer sheath was returned and was undamaged.Note: in the event description the user reported cutting the tip of the delivery wire and also cutting the introducing sheath.However, in the follow-up gfe questions, they stated that it was the tip of the delivery wire which was cut intentionally.The fact that the introducer sheath was intact aligns with this additional clarification.The stent delivery wire (sdw) was returned for analysis and was severely kinked/bent at multiple locations along it's length.The tip of the sdw was also broken/fractured approximately 1cm distal to the distal bumper.Presumably this is the cut which the user is referring to in the event description.In order to cut the sdw it would be necessary to advance it out of the introducer sheath.There are no instructions to do this included in the dfu (device directions for use).In fact, the dfu specifically states: carefully inspect the sterile package and neuroform ez stent system prior to use to verify that neither has been damaged during shipment.Do not use kinked or damaged components.There are also multiple references and cautions in the dfu on how to handle the system during preparation and transfer in order to prevent stent movement and premature deployment.The fact that [1] the stent ro marker bands could not be seen under dsa when the microcatheter was correctly placed for stent deployment, [2] the marker bands (and therefore the stent) could not be seen when the microcatheter was removed from the patient and [3] the same microcatheter was used to deploy a new stent (meaning the original stent had not been deployed somewhere inside the microcatheter lumen) is evidence that the stent was no longer present at the end of the sdw.It is highly likely that the off-label preparation activity which was undertaken to cut the tip of the sdw resulted in the stent becoming inadvertently deployed during device preparation.The as reported 'ro marker(s) detached/separated/not visible under fluoroscopy' and 'missing/incorrect device/component' will be assigned not confirmed.The as analyzed 'sdw kinked/bent' and 'sdw broken/fractured during preparation' will be assigned use error as this complaint appears to be associated with a product that met stryker design and manufacturing specifications but the event description states that the user did not follow the dfu instruction when they intentionally cut the tip of the sdw.This act resulted in a different medical product response than intended by the manufacturer and/or expected by the user.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: NEUROFORM 3 EZ 3.5MM X 20MM - 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: 18160332
• MDR Text Key: 328409444
• Report Number: 3008881809-2023-00555
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EN3E35200
• Device Lot Number: 24113462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2023
• 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: COIL (UNKNOWN); SYNCHRO GUIDEWIRE (STRYKER); XT-27 CATHETER (STRYKER)
• Patient Race: Asian