MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during coil embolization with the coil (subject device), the coil stretched while delivering into the aneurysm.The coil was successfully removed from the patient body with a snare device.There were no patient clinical consequences reported.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The product was not returned, therefore physical and functional tests could not be performed.There are many potential root causes for the as reported event, however a review and analysis of all available information cannot determined the exact cause for the reported event which led to the use of snare device.
Event or Problem Description
It was reported that during coil embolization with the coil (subject device), the coil stretched while delivering into the aneurysm.The coil was successfully removed from the patient body with a snare device.There were no patient clinical consequences reported.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6745954
• Report Number: 3008881809-2017-00221
• Device Sequence Number: 725143
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: (01)04546540676559(17)190430(10)19006264
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K112385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

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: 04/30/2019
• Device Model Number: M0035476300
• Device Catalogue Number: M0035476300
• Device Lot Number: 19006264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 09/26/2017
• 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: Required Intervention