MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ- 4.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E45200

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

This is 1 of 5 (1 stent and 4 coils) reports filed for the reported event.The subject device remains implanted.

Event Description

The patient underwent successful stent assisted coil embolization of a left posterior communicating artery aneurysm.It was reported that approximately 32 months post the index procedure the patient underwent additional coil embolization due to aneurysm recanalization.Approximately 30 days post re-treatment, the patient experienced transient ischemic attacks (tia) due to discontinuation of the clopidogrel medication.However, it was reported that it was unknown when the tia had started.The clopidogrel was re-started in response to the event.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 attack is a known risk associated with endovascular procedures and is noted as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

The patient underwent successful stent assisted coil embolization of a left posterior communicating artery aneurysm.It was reported that approximately 32 months post the index procedure the patient underwent additional coil embolization due to aneurysm recanalization.Approximately 30 days post re-treatment, the patient experienced transient ischemic attacks (tia) due to discontinuation of the clopidogrel medication.However, it was reported that it was unknown when the tia had started.The clopidogrel was re-started in response to the event.No further information is available.

• Brand Name: NEUROFORM 3 EZ- 4.5 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: 5973622
• MDR Text Key: 55479575
• Report Number: 3008881809-2016-00189
• 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
• Report Date: 08/29/2016

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: 06/30/2015
• Device Catalogue Number: M003EN3E45200
• Device Lot Number: 15376826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2012
• 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
• Treatment: 4 TARGET COILS (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 59 YR