MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3.5MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035423580

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 fifth 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.

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.

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.

• Brand Name: TARGET 360 ULTRA 3.5MM X 8CM
• 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: 7192161
• MDR Text Key: 97307953
• Report Number: 3008881809-2018-00038
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• 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: 04/30/2018
• Device Catalogue Number: M0035423580
• Device Lot Number: 18345163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2015
• 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
• Patient Age: 69 YR