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

Model Number	M0035422040
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Premature Activation (1484)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	12/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the coil embolization procedure for multiple aneurysms (aoma, right ica pcoma), it was reported that the main coil prematurely detached and dropped during reposition.The patient reported experienced distal vascular obstruction.No further information is available for now.
Additional Manufacturer Narrative
Outcomes attributed to ae: added ¿required intervention to prevent permanent impairment/damage (devices)¿ based on additional information received on 28-jan-2018.
Event or Problem Description
During the coil embolization procedure for multiple aneurysms (aoma, right ica pcoma), it was reported that the main coil prematurely detached and dropped during reposition.The patient reported experienced distal vascular obstruction.And unspecified medical intervention was provided to the patient as a result of the reported event.
Additional Manufacturer Narrative
Outcomes attributed to ae: added ¿required intervention to prevent permanent impairment/damage (devices)¿ based on additional information received on 28-jan-2018.Executive summary: updated based on additional information received on 28-jan-2018 in the 1st follow up report.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Information available indicated that the device was confirmed to be in good condition after unpacking and the device was prepared as per the dfu.Based on the information currently available, it is probable that the reported patient thrombosis occurred as a result of the main coil premature detachment inside patient and main coil migration during reposition, therefore an assignable cause of operational context will be assigned to the main coil prematurely detached inside patient, main coil migrated and patient thrombosis, as the issue is associated with a product that meets the design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.
Event or Problem Description
During the coil embolization procedure for multiple aneurysms (aoma, right ica pcoma), it was reported that the main coil prematurely detached and dropped during reposition.The patient reported experienced distal vascular obstruction.And unspecified medical intervention was provided to the patient as a result of the reported event.

• Brand Name: TARGET 360 ULTRA 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: 7220827
• Report Number: 3008881809-2018-00050
• Device Sequence Number: 801796
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: (01)04546540675842(17)181031(10)18657432
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K153658
• 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,Followup
• Report Date (Section B): 04/18/2018

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: 10/31/2018
• Device Model Number: M0035422040
• Device Catalogue Number: M0035422040
• Device Lot Number: 18657432
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/28/2018; 03/22/2018
• Initial Report FDA Received Date: 01/25/2018
• Supplement Report FDA Received Date: 02/15/2018; 04/18/2018
• 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: 72 YR
• Patient Weight: 51