MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035472040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Rupture (2208)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device remains implanted.
Event or Problem Description
It was reported that during a coil embolization procedure, the coil (subject device) ruptured the aneurysm.The patient was treated with a ventricular shunt.The physician stated that the procedural complications were not related to the stryker coil.There is no further information available.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.Aneurysm rupture and patient retreat (patient complications) are known risks associated with endovascular procedures and is noted as such in the device directions for use (dfu); therefore, anticipated in nature; therefore, an assignable cause of known inherent risk of procedure was assigned to this event.
Event or Problem Description
It was reported that during a coil embolization procedure, the coil (subject device) ruptured the aneurysm.The patient was treated with a ventricular shunt.The physician stated that the procedural complications were not related to the stryker coil.There is no further information available.

• Brand Name: TARGET 360 SOFT 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7594827
• Report Number: 3008881809-2018-00259
• Device Sequence Number: 275012
• Product Code: HCG
• UDI-Device Identifier: 07613252192701
• UDI-Public: 07613252192701
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: 11/30/2020
• Device Catalogue Number: M0035472040
• Device Lot Number: 20129525
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 06/14/2018
• 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