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

Catalog Number M0035422040

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

Patient Problems Hematoma (1884); Visual Disturbances (2140)

Event Date 09/22/2015

Event Type  Injury  

Manufacturer Narrative

This is the 2nd of 5 (coils) reports filed associated with this event.Subject devices remain implanted.

Event Description

The patient underwent successful stent assisted coil embolization of an aneurysm located in the anterior communicating artery.It was reported that approximately 1 month post-procedure, the patient experienced diplopia (double vision).The event was resolved without any residual effects.The patient was neurologically assessed as having post-procedure mrs of 0.According to the physician, it is possible that the diplopia be related to the stent and to the procedure; it is unknown if the diplopia was related to the implanted coils (subject devices).The patient was neurologically assessed as having a nihss of 0 and mrs of 1 at 2-month follow-up.Approximately 7-month post-procedure, the patient suffered a subdural hematoma due to fall that lasted 17 days.The subdural hematoma was resolved with residual effects.Prolonged hospitalization was required.According to the physician, the subdural hematoma was not related to the procedure, or stent; however, it was unknown if it was related to the implanted coils.The patient was neurologically assessed as having mrs of 4 at 8-month follow-up.

Manufacturer Narrative

Expiration date: added.Manufacturing date: added.Patient code: based on medical assessment, it was concluded that the event of subdural hematoma was not related to the coils.Therefore, previously filed patient code of hematoma is no longer applicable to this report.Outcomes attributed to ae: corrected: since hematoma is not an event associated with the coils, the previously outcome attributed of "hospitalization-initial or prolonged" is no longer applicable to this report.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was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, neurological/intracranial sequelae (visual disturbances) is a known risk 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 aneurysm located in the anterior communicating artery.It was reported that approximately 1 month post-procedure, the patient experienced diplopia (double vision).The event was resolved without any residual effects.The patient was neurologically assessed as having post-procedure mrs of 0.According to the physician, it is possible that the diplopia be related to the stent and to the procedure; it is unknown if the diplopia was related to the implanted coils (subject devices).The patient was neurologically assessed as having a nihss of 0 and mrs of 1 at 2-month follow-up.Approximately 7-month post-procedure, the patient suffered a subdural hematoma due to fall that lasted 17 days.The subdural hematoma was resolved with residual effects.Prolonged hospitalization was required.According to the physician, the subdural hematoma was not related to the procedure, or stent; however, it was unknown if it was related to the implanted coils.The patient was neurologically assessed as having mrs of 4 at 8-month follow-up.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• 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: 6845807
• MDR Text Key: 85014223
• Report Number: 3008881809-2017-00289
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102672
• 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: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: M0035422040
• Device Lot Number: 18249881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2015
• 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
• Treatment: FOUR (4) TARGET COILS (STRYKER); TWO (2) NEUROFORM ATLAS STENTS (STRYKER)
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 69 YR