MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035442040

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

Patient Problems Stroke/CVA (1770); Embolism (1829); Neurological Deficit/Dysfunction (1982)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

This is the 2nd of 2 reports.Subject device remains implanted.

Event Description

It was reported that the patient was pre-treated with 5 days of platelet aggregation inhibitors (plavix/asa) and then underwent successful stent-assisted coil (subject device) embolization of an aneurysm located at the right post communicating artery (r-pcomm).Five to six hours post procedure, the patient experienced stroke-like symptoms at the parietal lobe.Emergent computed tomography angiography (cta) did not reveal significant clot.Follow-up magnetic resonance imaging (mri) revealed tiny embolic cva (cerebrovascular accident) at the middle cerebral artery (mca) territory in the motor strip.Heparin was administered.According to the physician, the clotting/stroke was possibly related to either the stent or the coil mass at the pcomm artery.The patient neurological deficits resulting from the stroke were resolved after 4 days.

Event Description

It was reported that the patient was pre-treated with 5 days of platelet aggregation inhibitors (plavix/asa) and then underwent successful stent-assisted coil (subject device) embolization of an aneurysm located at the right post communicating artery (r-pcomm).Five to six hours post procedure, the patient experienced stroke-like symptoms at the parietal lobe.Emergent computed tomography angiography (cta) did not revealed significant clot.Follow-up magnetic resonance imaging (mri) revealed tiny embolic cva (cerebrovascular accident) at the middle cerebral artery (mca) territory in the motor strip.Heparin was administered.According to the physician, the clotting/stroke was possibly related to either the stent or the coil mass at the pcomm artery.The patient neurological deficits resulting from the stroke were resolved after 4 days.

Manufacturer Narrative

A review of the device history record could not be performed because the lot number was not reported.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, adverse events associated with the use of coil or with the endovascular procedures include, but are not limited to: stroke, emboli and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.

• Brand Name: TARGET 360 NANO 2 MM X 4 CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7318448
• MDR Text Key: 101662177
• Report Number: 3008881809-2018-00101
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

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 Catalogue Number: M0035442040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEUROFORM ATLAS STENT (STRYKER); NEUROFORM ATLAS STENT (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 84 YR