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

Catalog Number M003EN3E45150

Device Problems Premature Activation (1484); Difficult or Delayed Activation (2577)

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

Event Date 01/20/2024

Event Type  malfunction  

Event Description

It was reported that during internal carotid artery (ica) stenosis stenting case, subject stent was used along with microcatheter, and it got partially deployed while withdrawing the microcatheter to deploy the stent.Due to tortuous area operator decided to use intermediate catheter to re-capture the microcatheter and subject stent together but during this process subject stent prematurely deployed in intermediate catheter.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.

Event Description

It was reported that during internal carotid artery (ica) stenosis stenting case, subject stent was used along with microcatheter, and it got partially deployed while withdrawing the microcatheter to deploy the stent.Due to tortuous area operator decided to use intermediate catheter to re-capture the microcatheter and subject stent together but during this process subject stent prematurely deployed in intermediate catheter.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was observed that the subject stent and stent introducer sheath was not returned for analysis.The stent delivery wire (sdw) was noted to be kinked/bent from the distal tip up to 9cm.Note: the sdw is pre-shaped but also noted to be kinked/bent.Functional testing could not be performed as subject stent 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 reported 'stent partial deployment' and 'stent deployed prematurely during use' could not be confirmed during analysis.However, the analysis results are consistent with the reported event.The sdw part of the device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer 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, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was described as 'moderately tortuous'.It was reported that 'the operator placed microcatheter to the location and then placed subject stent to reach lesion.Withdrew the microcatheter to deploy the stent for about 1/3 and then the stent was at a tortuous area so the rest of the stent could not be deployed.The operator then placed intermediate catheter to withdraw the microcatheter and subject stent out together.During this procedure the stent deployed at distal of intermediate catheter.The event description indicated that the subject stent was being used in a stenosis case which is not recommended.The subject stent dfu states "the micro-delivery stent system is authorized by european law for use with occlusive devices in the treatment of intracranial aneurysms".The subject stent was not returned for analysis and neither was the introducer sheath.Part of what is presumed to be the intermediate catheter was returned but the stent was not present inside this section of returned catheter.The sdw was returned for analysis and was kinked/bent towards the distal end.It is not clear how this damage to the sdw occurred but it is likely that there was a lot of manipulation of the sdw during the attempted deployment and, afterwards, when the microcatheter and the stent system (stent and sdw) were removed using the intermediate catheter.The as reported codes 'stent partial deployment' and 'stent deployed prematurely during use' will be assigned undeterminable as the stent was not available for analysis.The as analysed code ¿sdw kinked/bent¿ 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.

• 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: 18683604
• MDR Text Key: 335071157
• Report Number: 3008881809-2024-00058
• 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: 04/03/2024

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: M003EN3E45150
• Device Lot Number: 24162041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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: EXCELSIOR XT-27 MICROCATHETER (STRYKER).; SOFIA CATHETER (MICROVENTION).
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: Asian