MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036126200

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

The subject device is unavailable to manufacturer.

Event Description

It was reported that when the subject coil was embolized, blood flow was stagnant due to deviation/migration of the subject coil loop from aneurysm to mother blood vessel and adhesion of thrombus occurred.Therefore, the stent was implanted at the a-com.At that time, an unknown guidewire was inserted to remove the catheter and collected together.When an unknown guidewire was removed, the coating of the unknown guidewire appeared on the lumen of the catheter.There was no health damage to the patient.No other information was provided.

Event Description

It was reported that when the subject coil was embolized, blood flow was stagnant due to deviation/migration of the subject coil loop from aneurysm to mother blood vessel and adhesion of thrombus occurred.Therefore, the stent was implanted at the a-com.At that time, an unknown guidewire was inserted to remove the catheter and collected together.When an unknown guidewire was removed, the coating of the unknown guidewire appeared on the lumen of the catheter.There was no health damage to the patient.No other information was provided.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It was reported that during the procedure, blood flow was stagnant due to deviation/migration of the coil loop into the parent vessel and adhesion of thrombus occurred when the subject coil was embolized which required medical intervention (atlas stent implantation in the a-com).Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the tortuosity of the patient's anatomy was average.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: TARGET XL 360 SOFT 6MM X 20CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11564793
• MDR Text Key: 242172943
• Report Number: 3008881809-2021-00137
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: 07613327004625
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: M0036126200
• Device Catalogue Number: M0036126200
• Device Lot Number: 22395232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATLAS STENT (STYKER); GUIDEWIRE (UNKNOWN MANUFACTURER); XT-17 CATHETER (STRYKER)
• Patient Outcome(s): Other; Required Intervention