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

Catalog Number M003EN3E40150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

This is 1 of 2 reports for this event.The device remains implanted in the patient.

Event Description

It was reported that a coil embolization procedure was successfully performed for a right parasellar lesion aneurysm with a coil and the subject stent.Approximately 2.5 years later, a magnetic resonance imaging (mri) indicated a transient ischemic attack (tia) with a one-sided paralysis at the right frontal lobe.Therefore, the patient's aspirin dosage was raised and the patient recovered approximately 5 months later.No further information is available.

Event Description

It was reported that a coil embolization procedure was successfully performed for a right parasellar lesion aneurysm with a coil and the subject stent.Approximately 2.5 years later, a magnetic resonance imaging (mri) indicated a transient ischemic attack (tia) with a one-sided paralysis at the right frontal lobe.Therefore, the patient's aspirin dosage was raised and the patient recovered approximately 5 months later.No further information is available.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, transient ischemic attacks are known risks associated with endovascular procedures and is noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported that a coil embolization procedure was successfully performed for a right parasellar lesion aneurysm with a coil and the subject stent.Approximately 2.5 years later, a magnetic resonance imaging (mri) indicated a transient ischemic attack (tia) with a one-sided paralysis at the right frontal lobe.Therefore, the patient's aspirin dosage was raised and the patient recovered approximately 5 months later.No further information is available.

• Brand Name: NEUROFORM 3 EZ- 4.0 X 15MM
• 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 CA NA
• Manufacturer Contact: sanda dracic ; 47900 bayside parkway; model farm road; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5731126
• MDR Text Key: 47585604
• Report Number: 3008881809-2016-00039
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: M003EN3E40150
• Device Lot Number: 14932279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/17/2016; 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR