MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 2.5MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E25150

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

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

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the middle cerebral artery m1 occlusion re-open treatment, the physician used the guidewire to deliver the microcatheter to the target lesion and deployed the subject stent.When withdrawing the microcatheter and the stent delivery wire, it got stuck.The physician added some force to withdraw the stent delivery wire due to that the subject stent moved away from the target lesion site where it was deployed.The subject stent could not be retracted and remains inside the patient's anatomy.The patient is doing well and has no impact due to this event.The physician used another device to finish the procedure without any clinical consequences.

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the middle cerebral artery m1 occlusion re-open treatment, the physician used the guidewire to deliver the microcatheter to the target lesion and deployed the subject stent.When withdrawing the microcatheter and the stent delivery wire, it got stuck.The physician added some force to withdraw the stent delivery wire due to that the subject stent moved away from the target lesion site where it was deployed.The subject stent could not be retracted and remains inside the patient's anatomy.The patient is doing well and has no impact due to this event.The physician used another device to finish the procedure without any clinical consequences.

Manufacturer Narrative

H3: device evaluated by mfg ¿updated.H3: summary attached - updated.H4: manufacturing date ¿ added.D4: expiration date - added.D10: product available to stryker ¿ updated.D10: returned to manufacturer on ¿updated.Due to the automated mes 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 not returned.The stent delivery wire (sdw) was found to be kinked/bent.The stent introducer sheath was not returned.The functional testing cannot be performed due to the subject stent was not returned for analysis.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.Addition information received indicated 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 also set up and maintained throughout the clinical procedure.It is reported that 'after deploying the stent normally, the operator withdrew the microcatheter and the guidewire but at that time he found the guidewire and the microcatheter got stuck and could not be withdrawn.Added some force to withdrew the guidewire and then the stent deployed unexpectedly at another position in ica and could not be retracted.The operator thought there might be some problem with the delivery wire'.It is assumed that the use of the word 'guidewire' in unintentional and that it refers to the stent deliver wire (sdw).This is based on 2 reasons: [1] there is a reference to 'delivery wire' towards the end of the event description, and [2] there is no reference to coiling so it is likely that this issue occurred during removal of the sdw & microcatheter from the stent.The patient was not impacted by this event.Note: per the subject stent direction for use (dfu): 'prior to removing the stent delivery wire, position the microcatheter distal to the stent to maintain access through the stent.Remove and discard the subject stent system'.If this instruction was adhered to it should not be possible for the delivery wire to get stuck in the stent.The stent was not returned for analysis as it had been deployed in the patient per the event description.The introducer sheath was also not returned for analysis.The sdw was returned and was noted to be kinked/bent.Based on the event description, it is possible that the damage noted to the sdw occurred when it was being removed after stent deployment.The as reported codes will be assigned undeterminable as the stent was deployed in the patient and was not available for analysis.The as analyzed 'sdw kinked/bent' code 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 the middle cerebral artery m1 occlusion re-open treatment, the physician used the guidewire to deliver the microcatheter to the target lesion and deployed the subject stent.When withdrawing the microcatheter and the stent delivery wire, it got stuck.The physician added some force to withdraw the stent delivery wire due to that the subject stent moved away from the target lesion site where it was deployed.The subject stent could not be retracted and remains inside the patient's anatomy.The patient is doing well and has no impact due to this event.The physician used another device to finish the procedure without any clinical consequences.

• Brand Name: NEUROFORM 3 EZ 2.5MM 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: 13591184
• MDR Text Key: 286057732
• Report Number: 3008881809-2022-00082
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H020002
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: M003EN3E25150
• Device Lot Number: 22481052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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 XT-27 MICROCATHETER (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: Asian