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

Model Number M0035442030

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

Patient Problem Dizziness (2194)

Event Date 05/20/2016

Event Type  Injury  

Manufacturer Narrative

This is the fourth of 5 records.Subject device remains implanted.

Event Description

It was reported that approximately 5 month post stent-assisted coil embolization of right internal carotid artery-ophthalmic artery, the patient experienced dizziness that was resolved the same day without residual effect.Mri was done and the patient was referred to follow up at balance center.The physician established that the dizziness was related to the procedure, to the stent, and to coils (subject devices).The patient was assessed neurologically after procedure and at 2 month post-procedure with mrs of 0.At 6 month and 12 month post-procedure, nihss and mrs were 0.

Event Description

It was reported that approximately 5 month post stent-assisted coil embolization of right internal carotid artery-ophthalmic artery, the patient experienced dizziness that was resolved the same day without residual effect.Mri was done and the patient was referred to follow up at balance center.The physician established that the dizziness was related to the procedure, to the stent, and to coils (subject devices).The patient was assessed neurologically after procedure and at 2 month post-procedure with mrs of 0.At 6 month and 12 month post-procedure, nihss and mrs were 0.

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, neurological sequelae such as dizziness 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.

• 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
• MDR Report Key: 7192157
• MDR Text Key: 97280160
• Report Number: 3008881809-2018-00037
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613252600312
• UDI-Public: (01)07613252600312(17)180831(10)18554640
• Combination Product (y/n): N
• PMA/PMN Number: K113412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: M0035442030
• Device Catalogue Number: M0035442030
• Device Lot Number: 18554640
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4 TARGET COILS (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 69 YR