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

Model Number	M0035421030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that endovascular aneurysmal coil embolization procedure was performed.After advancement of the target coil to the aneurysm, the subject coil was tried to detach using detachment system.Though the detachment system kept in the stable position and placement of marker was checked, even after three successful attempts to detach the subject coil by detachment system, it was unable to detach.The movement of coil was checked under fluoroscopy when detachment was performed.The distal portion of subject coil delivery wire was torn off/fractured when trying to advance the delivery wire for repositioning of it into the desired aneurysmal site.The physician was able to remove all parts of torn delivery wire from patient anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil was found to be detached, kinked/bent, and stretched.The detachment seems to be electrical/partially electrical.The coil delivery wire was found to be kinked bent in a few places, there was no breakage noted to the delivery wire.There was significant amount of procedural fluids noted on the detachment zone and on the main coil.The suture was found to be intact.Functional inspection was unable to perform due to coil damage.The reported delivery wire fracture was not confirmed, the reported failure to detach and false detachment signal can be confirmed based on the condition of the returned coil.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 returned detached from the delivery wire, it was kinked and stretched, there was evidence of electrolytic detachment and there was procedural fluids/blood/thrombus noted to the detachment zone, these are all contributing factors to failure to detach the coil.The delivery wire was noted to be kinked and not fractured, as was reported.It is probable that the main coil was damaged during the clinical procedure, this damage along with the presence of thrombus to the detachment zone probably caused the coil to partially detach, allowing it to be removed from the patient, it is probable that the coil was then fully detached once removed from the patient, this would explain how the coil was removed from the patient with evidence of electrolytic detachment.An assignable cause of procedural factors will be assigned to the reported ¿main coil failed/unable to detach¿ and ¿main coil false detachment signal¿ and to the analyzed ¿main coil kinked/bent¿ and ¿main coil stretched¿, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.It is probable that the delivery wire was damaged as a result of handling of the device during the clinical procedure, therefore an assignable cause of handling damage will be assigned to the analyzed ¿coil delivery wire kinked/bent¿.An assignable cause of not confirmed will be assigned to the reported ¿coil delivery wire broken/fractured during use¿, as the delivery wire was found not to be fractured.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that endovascular aneurysmal coil embolization procedure was performed.After advancement of the target coil to the aneurysm, the subject coil was tried to detach using detachment system.Though the detachment system kept in the stable position and placement of marker was checked, even after three successful attempts to detach the subject coil by detachment system, it was unable to detach.The movement of coil was checked under fluoroscopy when detachment was performed.The distal portion of subject coil delivery wire was torn off/fractured when trying to advance the delivery wire for repositioning of it into the desired aneurysmal site.The physician was able to remove all parts of torn delivery wire from patient anatomy.The physician replaced it with a new device and continued the procedure 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: 11822880
• Report Number: 3008881809-2021-00201
• Device Sequence Number: 13718409
• 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): 10/01/2021

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: 10/05/2023
• Device Model Number: M0035421030
• Device Catalogue Number: M0035421030
• Device Lot Number: 22479896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1