MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 3.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E35200

Device Problems Device Markings/Labelling Problem (2911); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that during coil embolization procedure for ophthalmic artery (oa) aneurysm.Micorcatheter was placed and the subject stent was delivered to the lesion; however, when the physician tried to deploy the stent, the distal and proximal marker of the stent were not visible under the fluoroscopy.The physician withdrew the catheter out of the patient¿s anatomy and the stent was not found inside the micorcatheter.Another stent was used to complete the procedure successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the stent delivery wire (sdw) and the introducer sheath were returned within the dispenser hoop.The stent was not returned.Kink was noted at 1.5cm from the distal tip of the sdw.A full functional testing was not performed since the stent was not returned for evaluation.The sdw moved freely within the introducer sheath.In case of this complaint, there were no anomalies noted to the stent prior to use and the device was prepared as per the direction for use (dfu).The reported issue stent deployed prematurely during use was confirmed during the device analysis; however, the stent was not returned; therefore, it cannot be determined what caused the reported ro marker(s) detached/separated/not visible under fluoroscopy.An assignable cause of undeterminable was assigned to the reported issue ro marker not visible under fluoroscopy, as a review and analysis of all available information failed to indicate as assignable cause or probable assignable cause.An assignable cause of procedural factors was assigned to the as reported issue stent deployed premature during use, as the issue is associated with a product that meets stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.Expiration date: added, manufacturing date: added, device evaluated by mfg: updated, summary attached: updated.

Event Description

It was reported that during coil embolization procedure for ophthalmic artery (oa) aneurysm.Microcatheter was placed and the subject stent was delivered to the lesion; however, when the physician tried to deploy the stent, the distal and proximal marker of the stent were not visible under the fluoroscopy.The physician withdrew the catheter out of the patient¿s anatomy and the stent was not found inside the microcatheter.Another stent was used to complete the procedure successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM 3 EZ- 3.5 X 20MM
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8553056
• MDR Text Key: 143245219
• Report Number: 3008881809-2019-00110
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: H020002
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: M003EN3E35200
• Device Lot Number: 20310529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• 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
• Patient Age: 58 YR
• Patient Weight: 70