MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035425150
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer, as device is implanted in patient.
Event or Problem Description
It was reported that the stent assisted coil embolization procedure was performed for ica (internal carotid artery) pcomp (posterior communicating artery) wide neck aneurysm.After delivering the microcatheter with guidewire into the lumen of targeted vessel, physician started aneurysmal coil embolization.The subject coil was placed and deployed as expected.But subject coil loop has migrated to the parent vessel as the neck of the aneurysm was too wide.So the physician has decided to deploy the stent first to support the coil mass at the neck of the aneurysm.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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 was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported issue is covered in the device directions for use.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 one loop of the coil migrated to parent vessel, so the operator decided to deploy the stent first.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 the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the anatomy of the patient's was not tortuous.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 was assigned to this complaint.
Event or Problem Description
It was reported that the stent assisted coil embolization procedure was performed for ica (internal carotid artery) pcomp (posterior communicating artery) wide neck aneurysm.After delivering the microcatheter with guidewire into the lumen of targeted vessel, physician started aneurysmal coil embolization.The subject coil was placed and deployed as expected.But subject coil loop has migrated to the parent vessel as the neck of the aneurysm was too wide.So the physician has decided to deploy the stent first to support the coil mass at the neck of the aneurysm.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 5MM X 15CM
• 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: 12086660
• Report Number: 3008881809-2021-00281
• Device Sequence Number: 14289982
• Product Code: HCG
• UDI-Device Identifier: 04546540675965
• UDI-Public: 04546540675965
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: M0035425150
• Device Catalogue Number: M0035425150
• Device Lot Number: 22569689
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 10/19/2021
• 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: SL-10 MICRO CATHETER (STRYKER).
• Patient Age: 50 YR