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 12/26/2022

Event Type  malfunction  

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.During visual inspection, the stent was seen deployed and deformed.The stent delivery wire was noted broken just after the distal bumper coil and the broken part of wire was not returned.The introducer sheath distal tip was seen damaged.Functional inspection was not performed as the stent was returned deployed and damaged.The reported device difficulty engaging target vessel could not be confirmed as this issue is patient procedural related issue.The reported stent deployed prematurely during retraction/re-sheathing was confirmed during analysis.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was returned for analysis, the stent was returned in the condition of fully deployed and deformed, confirming the reported premature deployment.The (sdw)- stent delivery wire was returned and found to be broken after the distal bumper coil, the broken distal section of the wire was not returned for device analysis and it is unclear from the analysis and the event description at what point the wire fracture occurred.In the absence of this information a worst case situation is presumed.Therefore, 'sdw broken/fractured during use' has been assigned as the as analyzed event code.The introducer sheath was returned and found to have damage to the distal tip.As per the available information "when delivering the stent and when it reached opening of aca, the plaque was too hard and the stent would not go though".Although the procedure successfully completed using a second stent, it is likely that the severe tortuosity of the target vessel combined with the hardened plaque would have contributed to the complication experienced and the damage noted to the device during analysis.The event description indicated that the subject stent was being used in a stenosis case which is not recommended.The subject stent dfu states "subject stent system is authorized by european law for use with occlusive devices in the treatment of intracranial aneurysms".The as reported events 'device difficulty engaging target vessel ' and 'stent deployed prematurely during retraction/re-sheathing' as well as the as analyzed events 'stent deployed prematurely during retraction/re-sheathing', 'stent deformed', 'sdw broken/fractured during use' and 'stent introducer sheath damaged' will be assigned with an assignable cause of 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 factors during use.

Event Description

Analysis of the returned device found that the stent delivery wire broke/fractured during use.The device was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• 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: 16513413
• MDR Text Key: 311061856
• Report Number: 3008881809-2023-00117
• 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
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• 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: 23832567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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: AXS CATALYST 5 CATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: Asian