MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pre-operative endovascular tumor embolization for the middle meningeal artery procedure was performed before brain tumor resection.During the endovascular embolization procedure, three branched blood vessels were embolized in the middle meningeal artery by using embosphere (embolic material) and four coils.During endovascular coil embolization procedure, while advancement of the subject coil into the distal portion of the microcatheter, resistance was noted.After placement of the subject coil at the embolic site, the subject coil was detached and detachment was also confirmed under fluoroscopy.While removal of the coil delivery wire post detachment, subject proximal portion of the subject coil was pulled back with the delivery wire into the microcatheter.Coil delivery wire was removed but coil was still attached to the microcatheter.Four attempts are made to placed the subject coil from microcatheter to the embolic site using guidewire and the procedure was completed successfully.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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.The coil was not returned as it was implanted, however the associated microcatheter was returned which was noted to be slightly damaged to the distal tip and blocked with dried blood, which are both contributory factors to the reported event.An assignable cause of procedural factors will be assigned to the reported event of main coil migration, coil in catheter friction and device interaction with another device, as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.H3 other text : the device is not available to the manufacturer, as device is implanted in patient.
Event or Problem Description
It was reported that pre-operative endovascular tumor embolization for the middle meningeal artery procedure was performed before brain tumor resection.During the endovascular embolization procedure, three branched blood vessels were embolized in the middle meningeal artery by using embosphere (embolic material) and four coils.During endovascular coil embolization procedure, while advancement of the subject coil into the distal portion of the microcatheter, resistance was noted.After placement of the subject coil at the embolic site, the subject coil was detached and detachment was also confirmed under fluoroscopy.While removal of the coil delivery wire post detachment, subject proximal portion of the subject coil was pulled back with the delivery wire into the microcatheter.Coil delivery wire was removed but coil was still attached to the microcatheter.Four attempts are made to placed the subject coil from microcatheter to the embolic site using guidewire and the procedure was completed successfully.

• Brand Name: TARGET 360 NANO 1.5MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11967463
• Report Number: 3008881809-2021-00234
• Device Sequence Number: 4414899
• Product Code: HCG
• UDI-Device Identifier: 04546540697943
• UDI-Public: 04546540697943
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: M0035421530
• Device Catalogue Number: M0035421530
• Device Lot Number: 21965706
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/13/2021
• 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: XT17 MICROCATHETER (STRYKER); XT17 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention