MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 4.0MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E40150

Device Problem Premature Activation (1484)

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

Event Date 03/24/2024

Event Type  malfunction  

Event Description

It was reported that during a neurovascular procedure the subject stent deployed unexpectedly in microcatheter.The subject stent along with the microcatheter were taken out of the patient's body.The subject stent and microcatheter were replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during a neurovascular procedure the subject stent deployed unexpectedly in microcatheter.The subject stent along with the microcatheter were taken out of the patient's body.The subject stent and microcatheter were replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was confirmed with the packaging returned with the device.During visual inspection, the device returned together with microcatheter device.The stent was found to be deployed inside the microcatheter and hub.The distal and middle part of the sdw (stent delivery wire) was found to be kinked/bent.The stent was found to be intact.The stent introducer sheath was found to be intact.During functional inspection: stent difficult/unable to transfer and stent difficult/unable to advance or pullback through catheter functional test was unable to be performed as the stent was found to be deployed.The stent deployed prematurely during use test was confirmed during visual inspection based on the stent deployed inside the microcatheter and the hub of the catheter.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.It was reported that the user placed a microcatheter and then delivered the stent after preparation but big resistance was encountered during delivery.Tried several times and the distal of the stent was pushed into microcatheter, but big resistance was still encountered during this procedure.After several tries the stent deployed unexpectedly (distal in microcatheter and rest in hub).So withdrew the stent and microcatheter out and used other stent and microcatheter to finish the procedure.Additional information received from the customer indicates that the device was prepared and used as intended.No user related issue was noted.The device was returned and the stent was returned prematurely deployed in the microcatheter and hub.The sdw was noted to have been kinked.It is probable that the stent deployed in the microcatheter and hub due to the introducer sheath distal tip not being adequately seated into the hub of the microcatheter or force and movement of the introducer sheath during the transfer attempt.It is also likely that the sdw was kinked as a result of this transfer difficulties experienced.An assignable cause of procedural factors has been assigned to the as reported events of stent difficult/unable to advance or pullback through catheter, stent difficult/unable to transfer and stent deployed prematurely during use and as analyzed events of stent deployed prematurely during use, stent deployed prematurely during transfer and sdw kinked/bent as this complaint appears to be associated with a product that met the manufacturers design and manufacturing specifications and was reported to have been used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: NEUROFORM 3 EZ 4.0MM 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: 19093679
• MDR Text Key: 340693035
• Report Number: 3008881809-2024-00160
• 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: 04/11/2024

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: M003EN3E40150
• Device Lot Number: 24337095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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: XT-27 MICROCATHETER (STRYKER)
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: Asian