MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421520
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Premature Activation (1484)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil prematurely detached and migrated to middle cerebral artery(mca).The coil was retrieved with gooseneck snare, but some clot was formed in anterior cerebral artery(aca )and middle cerebral artery(mca )area during coil retrieval.The clot was retrieved by thrombectomy and the coil embolization was completed after the thrombectomy.
Additional Manufacturer Narrative
Executive summary is update to include the anatomical location of the treatment area.Expiration date: added.Manufacturing date: added.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore analysis cannot be performed.As per additional information no damage was noted to the device prior to use and the device was prepared as per device direction for use (dfu) for this product.In the case of this complaint it is most likely that the main coil prematurely detached inside patient and migrated while attempting re-sheathing and repositioning due to some procedural factors encountered during the use thus resulting in patient thrombosis (untreated vessel).Therefore it is probable that the damage was sustained to the device during the clinical procedure limiting the performance of the device during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
It was reported that during the coil embolization procedure of the internal carotid- posterior communicating artery(ic-pc) ruptured aneurysm, the coil prematurely detached and migrated to middle cerebral artery(mca).The coil was retrieved with gooseneck snare, but some clot was formed in anterior cerebral artery(aca )and middle cerebral artery(mca )area during coil retrieval.The clot was retrieved by thrombectomy and the coil embolization was completed after the thrombectomy.

• Brand Name: TARGET 360 NANO 1.5MM X 2CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7181155
• Report Number: 3008881809-2018-00031
• Device Sequence Number: 11071918
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: (01)04546540697981(17)190630(10)19108900
• Combination Product (Y/N): N
• PMA/510(K) Number: K113412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 06/30/2019
• Device Model Number: M0035421520
• Device Catalogue Number: M0035421520
• Device Lot Number: 19108900
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 02/05/2018
• 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
• Patient Age: 42 YR