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

Catalog Number M0035422030

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

Patient Problem Visual Disturbances (2140)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

This is 2 of 2 reports filed for two coils implanted.The subject device remains implanted.

Event Description

The patient underwent successful stent assisted coil embolization of an un-ruptured aneurysm located in the right fetal posterior cerebral artery origin.Post procedure the patient was assessed having a mrs of 1.It was reported that approximately 16 days post the index procedure the patient experienced right eye blurred vision (diplopia).No treatment was administered as examination in clinic was unremarkable.Neuro-imaging was stable; no changes in aneurysm and evidence of cerebrovascular accident.The study facility reported that the blurred vision was possibly related to the procedure and implanted coils.At 2, 6 and 12 months follow up, the patient had a nihss of 0 and a mrs of 1.The blurred vision resolved without treatment and there was no residual effect.No further information is available.

Manufacturer Narrative

Manufacturer and expiration date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, neurological/intracranial sequelae is a known risks associated with endovascular procedures and is noted as such in the device direction for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.

Event Description

The patient underwent successful stent assisted coil embolization of an un-ruptured aneurysm located in the right fetal posterior cerebral artery origin.Post procedure the patient was assessed having a mrs of 1.It was reported that approximately 16 days post the index procedure the patient experienced right eye blurred vision (diplopia).No treatment was administered as examination in clinic was unremarkable.Neuro-imaging was stable; no changes in aneurysm and evidence of cerebrovascular accident.The study facility reported that the blurred vision was possibly related to the procedure and implanted coils.At 2, 6 and 12 months follow up, the patient had a nihss of 0 and a mrs of 1.The blurred vision resolved without treatment and there was no residual effect.No further information is available.

• Brand Name: TARGET 360 ULTRA 2MM X 3CM
• 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: 6903146
• MDR Text Key: 87715415
• Report Number: 3008881809-2017-00388
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: M0035422030
• Device Lot Number: 18362396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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: GDC COIL (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 64 YR