MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 3.0MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E30150

Device Problems Fracture (1260); Premature Activation (1484)

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

Event Date 08/04/2023

Event Type  malfunction  

Manufacturer Narrative

There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the stent was found to be deployed.The sdw (stent delivery wire) was found to be kinked/bent.The stent was found to be deformed and broken fractured.Functional testing was not completed due to device condition.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 complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed.The stent was found to be deployed.The stent was found to be deformed and broken/fractured.The sdw was found to be kinked/bent.The event description indicated that the neuroform ez stent was being used in a stenosis case which is not recommended.The neuroform ez dfu states "the neuroform microdelivery stent system is authorized by european law for use with occlusive devices in the treatment of intracranial aneurysms".As assignable cause of procedural factors will be assigned to the as reported event of stent difficult/unable to advance or pullback through catheter.To the as reported and as analyzed event of stent deformed and the as analyzed event of stent broken/fractured during use, stent deployed prematurely during use and sdw kinked/bent as these defects appear to be associated with a product that met stryker design and manufacturing specifications, but performance was limited due to procedural and/or anatomical factors during use.

Event Description

The stent (subject device) was returned for analysis and the device investigation revealed that the stent (subject device) was fractured during use and prematurely deployed during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM 3 EZ 3.0MM 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: 17977357
• MDR Text Key: 326178218
• Report Number: 3008881809-2023-00512
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EN3E30150
• Device Lot Number: 24174248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• 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: REBAR27 MICROCATHETER (MEDTRONIC)