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

Model Number M0035422040

Device Problems Migration or Expulsion of Device (1395); Premature Activation (1484)

Patient Problem Thrombosis (2100)

Event Date 12/27/2017

Event Type  Injury  

Manufacturer Narrative

The subject device is not available.

Event 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.

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 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.

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 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
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 7220827
• MDR Text Key: 98277109
• Report Number: 3008881809-2018-00050
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: (01)04546540675842(17)181031(10)18657432
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 51