MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035474100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Visual Disturbances (2140)
Date of Event	10/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the 3rd of 5 (coils) reports filed associated with this event.Subject devices remain implanted.
Event or Problem Description
The patient underwent successful stent-assisted coil embolization of an aneurysm located in the left internal carotid artery (ica) ophthalmic segment.Post-procedure the patient was neurologically assessed as having a mrs (modified ranking scale) of 0.16 days post-procedure, the patient experienced headache that lasted 9 days.Medications prochlorperazine 10 mg iv and diphenhydramine 12.5 mg were administered on the 19 days post-procedure as out-patient in emergency department (ed) in order to treat the headache.Prescriptions for compazine 10 mg po and benadryl 25 mg po were given to the patient when discharged from ed.The headache was resolved without any residual effects.According to the physician, the headache was probably related to the procedure and to the stent.It was unknown if the headache was related to the implanted coils.The patient was assessed having a mrs of 0 at 2-month post-index procedure.
Additional Manufacturer Narrative
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 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 or Problem Description
The patient underwent successful stent-assisted coil embolization of an aneurysm located in the left internal carotid artery (ica) ophthalmic segment.Post-procedure the patient was neurologically assessed as having a mrs (modified ranking scale) of 0.16 days post-procedure, the patient experienced headache that lasted 9 days.Medications prochlorperazine 10 mg iv and diphenhydramine 12.5 mg were administered on the 19 days post-procedure as out-patient in emergency department (ed) in order to treat the headache.Prescriptions for compazine 10 mg po and benadryl 25 mg po were given to the patient when discharged from ed.The headache was resolved without any residual effects.According to the physician, the headache was probably related to the procedure and to the stent.It was unknown if the headache was related to the implanted coils.The patient was assessed having a mrs of 0 at 2-month post-index procedure.
Additional Manufacturer Narrative
Executive summary: corrected: additional adverse events of photophobia, intermittent blurred vision were added.Patient code: added.Additional adverse events of photophobia, intermittent blurred vision were 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 and neurological/intracranial sequelae (photophobia and intermittent blurred vision) are 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 or Problem Description
The patient underwent successful stent-assisted coil embolization of an aneurysm located in the left internal carotid artery (ica) ophthalmic segment.Post-procedure the patient was neurologically assessed as having a mrs of 0 (modified ranking scale).16 days post-procedure, the patient experienced headache that lasted 9 days.Medications prochlorperazine 10 mg iv and diphenhydramine 12.5 mg were administered on the 19 days post-procedure as out-patient in emergency department (ed) in order to treat the headache.Prescriptions for compazine 10 mg po and benadryl 25 mg po were given to the patient when discharged from ed.The headache was resolved without any residual effects.It was also reported that 16 days post-procedure, the patient experienced photophobia and intermittent blurred vision that lasted 9 days and were resolved without residual effects.According to the physician, the headache, the photophobia and intermittent blurred vision were probably related to the procedure and to the stent.It was unknown if the headache the photophobia and intermittent blurred vision were related to the implanted coils.The patient was assessed having a mrs of 0 at 2-month post-index procedure.

• Brand Name: TARGET 360 SOFT 4MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6853524
• Report Number: 3008881809-2017-00299
• Device Sequence Number: 10884688
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: (01)07613252192756(17)190531(10)19040674
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K102672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: M0035474100
• Device Catalogue Number: M0035474100
• Device Lot Number: 19040674
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 09/29/2017; 11/29/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 10/25/2017; 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 48 YR