MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number UNK_NEU

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

Patient Problems Edema (1820); Headache (1880)

Event Date 01/16/2015

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

The journal of neuro-endovascular therapy (jnet-p006) published that a patient underwent coil embolization of an aneurysm in the left internal carotid-posterior communicating artery a day post ct scan.The coil embolization procedure finished with neck remnant; therefore, the patient underwent successful re-embolization with stent assisted technique.Mri performed before discharge did not reveal any anomalies.It was reported that approximately 30 days after procedure, follow up mri image showed brain edema on the left and right frontal lobe and left occipital lobe.Symptoms experienced by the patient was only reported as a light headache.Further follow up approximately two months post procedure, revealed that the edema previously located on the frontal lobes had disappeared.Follow up approximately five months after initial mri findings revealed that brain edema on the left occipital lob remained unchanged.No neurological abnormalities were observed on the patient.No further information is available.

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, headache and neurological/intracranial sequelae are known risks associated with endovascular procedures and are listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.

Event Description

The journal of neuroendovascular therapy (jnet-p006) published that a patient underwent coil embolization of an aneurysm in the left internal carotid-posterior communicating artery a day post ct scan.The coil embolization procedure finished with neck remnant; therefore, the patient underwent successful re-embolization with stent assisted technique.Mri performed before discharge did not reveal any anomalies.It was reported that approximately 30 days after procedure, follow up mri image showed brain edema on the left and right frontal lobe and left occipital lobe.Symptoms experienced by the patient was only reported as a light headache.Further follow up approximately two months post procedure, revealed that the edema previously located on the frontal lobes had disappeared.Follow up approximately five months after initial mri findings revealed that brain edema on the left occipital lob remained unchanged.No neurological abnormalities were observed on the patient.No further information is available.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5358863
• MDR Text Key: 35607243
• Report Number: 3008853977-2016-00008
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 53 YR