MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 3.5MM X 30MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E35300

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Device not received for evaluation yet.

Event Description

It was reported that while attempting to advance the stent (subject device) in the catheter, the physician felt resistance and could not deploy the stent after several attempts.When the physician removed the stent, it was found partially deployed.The stent was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.

Manufacturer Narrative

A ¿ patient information ¿ updated.D1 ¿ product information - updated.D4- expiration date- updated.H2- follow up type- updated.H3- device evaluated- updated.H4- manufacture date- updated.The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and it was observed the stent was seen to be partially deployed and the sheath was retracted to expose the stent and it was seen to be intact.Functional testing revealed that the stent deployed successfully when sheath was retracted.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.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 event was confirmed.The device was returned and the stent was partially deployed in the sheath.This occurred while advancing the stent through the catheter during the procedure.It is probable that the device was damaged during the clinical procedure due to some procedural/anatomical factors encountered causing the as reported event, therefore assignable cause of procedural factors will be assigned to reported issue.

Event Description

It was reported that while attempting to advance the stent (subject device) in the catheter, the physician felt resistance and could not deploy the stent after several attempts.When the physician removed the stent, it was found partially deployed.The stent was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.

• Brand Name: NEUROFORM 3 EZ 3.5MM X 30MM - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9477402
• MDR Text Key: 176102935
• Report Number: 3008881809-2019-00394
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H020002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Catalogue Number: M003EN3E35300
• Device Lot Number: 21267882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICROCATHETER: XT-27 (STRYKER)
• Patient Age: 41 YR
• Patient Weight: 77