MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421030
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported that during the procedure when the guidewire was inserted to remove the catheter, the proximal part of the previously detached coil (subject device) stuck to the tip of the catheter.An attempt was made to release the subject coil from the catheter with a guiding catheter unsuccessfully.The subject coil migrated from inside the aneurysm, came off the catheter tip and became entangled with a previously placed stent.The subject coil was then successfully removed with a snare.The procedure was completed successfully without clinical consequences to the patient.
Additional Manufacturer Narrative
The device was not returned for evaluation.Due to the automated mes/dhr system there are controls in the manufacturing process to ensure the product met specifications upon release.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 reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that after detachment, the proximal part of the coil was fixed to the tip of the microcatheter, and the situation did not change even if it was pushed out with synchro2 soft guidewire.After that, when the same operation was performed, the coil deviated from the aneurysm, and an attempt was made to collect it with a guiding catheter (5 fr envoy) while the coil is still attached to the tip of sl-10.However, it could not be collected.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.H3 other text: device not returned for evaluation.
Event or Problem Description
It was reported that during the procedure when the guidewire was inserted to remove the catheter, the proximal part of the previously detached coil (subject device) stuck to the tip of the catheter.An attempt was made to release the subject coil from the catheter with a guiding catheter unsuccessfully.The subject coil migrated from inside the aneurysm, came off the catheter tip and became entangled with a previously placed stent.The subject coil was then successfully removed with a snare.The procedure was completed successfully without clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 1MM 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: 11579615
• Report Number: 3008881809-2021-00143
• Device Sequence Number: 3460551
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: 04546540697974
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/22/2021

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: 11/02/2023
• Device Model Number: M0035421030
• Device Catalogue Number: M0035421030
• Device Lot Number: 22547842
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 06/22/2021
• 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: 5 FR ENVOY GUIDE CATHETER (CODMAN NEURO); 5 FR ENVOY GUIDING CATHETER (UNKNOWN); ATLAS STENT (STRYKER); SL-10 CATHETER (STRYKER); SL-10 CATHETER (STRYKER); SNARE (UNKNOWN); SYNCHRO 2 GUIDEWIRE (STRYKER); SYNCHRO2 SOFT GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention