MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 3 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035442030

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

Patient Problems Headache (1880); Nausea (1970); Visual Disturbances (2140); Vomiting (2144)

Event Date 08/06/2015

Event Type  Injury  

Manufacturer Narrative

This is the 4th of 13 reports filed associated with this event.Subject device remains implanted.

Event Description

The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the anterior communicating artery (acom).Post-procedure the patient was assessed having a modified ranking scale (mrs) of 0.It was reported that on the day of the procedure the patient experienced headache and medication was administered.The headache lasted approximately 1 month post-procedure and was resolved without any residual effects.Approximately 45 days post procedure, the patient experienced migraine syndrome including nausea, vomiting, and unequal pupils; however, ct scan was negative.Medication (unknown type and dose) was administered and out-patient visit to the emergency department was required.According to the physician, the headache was possibly related to the procedure and stent.In addition, the physician indicated that the migraine was unrelated to the procedure and possibly related to the stent.However, it is unknown if the headache and migraine were related to implanted coils (subject device) and access devices.During the 2 and 6 months follow-up, the patient was assessed having a mrs of 0.At the 12 months follow-up post the index procedure, the patient was assessed having a nihhs and mrs of 0.The patient did not report headaches after the 6 months visit but the migraine syndrome was still intermittently continuing.No further information is available.

Manufacturer Narrative

Expiration date: added.Manufacturing date: added.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However headache including migraine syndrome and neurological/intracranial sequelae (nausea, vomiting, unequal pupils) are known risks associated with endovascular procedures and 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

The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the anterior communicating artery (acom).Post-procedure the patient was assessed having a modified ranking scale (mrs) of 0.It was reported that on the day of the procedure the patient experienced headache and medication was administered.The headache lasted approximately 1 month post-procedure and was resolved without any residual effects.Approximately 45 days post procedure, the patient experienced migraine syndrome including nausea, vomiting, and unequal pupils; however, ct scan was negative.Medication (unknown type and dose) was administered and out-patient visit to the emergency department was required.According to the physician, the headache was possibly related to the procedure and stent.In addition, the physician indicated that the migraine was unrelated to the procedure and possibly related to the stent.However, it is unknown if the headache and migraine were related to implanted coils (subject device) and access devices.During the 2 and 6 months follow-up, the patient was assessed having a mrs of 0.At the 12 months follow-up post the index procedure, the patient was assessed having a nihhs and mrs of 0.The patient did not report headaches after the 6 months visit but the migraine syndrome was still intermittently continuing.No further information is available.

• Brand Name: TARGET 360 NANO 2 MM X 3 CM
• 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: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6873822
• MDR Text Key: 86554207
• Report Number: 3008881809-2017-00341
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: M0035442030
• Device Lot Number: 18193783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• 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: 54 YR