MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 20MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036102050
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that during coil embolization of a big aneurysm, the subject coil detached prematurely and a very tiny filament was observed.The physician was not able to advance the microcatheter; therefore, the coil was retrieved with the microcatheter.The filament was left inside the patient¿s artery.No other patient consequences reported.No other additional information was provided.
Additional Manufacturer Narrative
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, visual, dimensional and functional testing could not be performed.In the case of this complaint, it is possible that the coil was detached during reposition and some fragments break from the coil due to some procedural factors encountered during use which were left inside the patient, this however cannot be conclusively determined.An assignable cause of undeterminable was assigned to the as reported issues, 'nv- main coil prematurely detached/separated inside patient, 'nv - coil broken/fractured ', and ' un-retrieved device fragments '.
Event or Problem Description
It was reported that during coil embolization of a big aneurysm, the subject coil detached prematurely and a very tiny filament was observed.The physician was not able to advance the microcatheter; therefore, the coil was retrieved with the microcatheter.The filament was left inside the patient¿s artery.No other patient consequences reported.No other additional information was provided.

• Brand Name: TARGET XL 360 STANDARD 20MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7768929
• Report Number: 3008881809-2018-00337
• Device Sequence Number: 10820024
• Product Code: HCG
• UDI-Device Identifier: 07613327004731
• UDI-Public: 07613327004731
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: M0036102050
• Device Lot Number: 19909557
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XT-17 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other