MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent-assisted endovascular aneurysmal coil embolization procedure was performed for acoma (anterior communicating artery) wide neck lobulated rupture aneurysm.The patient was reported to have moderately tortuous vascular anatomy.During the procedure guide catheter was placed to the right ica (internal carotid artery) c2 segment and the operator used guidewire for placing microcatheter at a2 for used.Then new microcatheter was placed to super selected to the lumen of aneurysm and aneurysmal coil embolization was performed.Stenting was performed to cover the neck of the aneurysm.When the operator tried to do coil embolization with the subject coil post stenting, while adjusting embolization before detachment, the subject coil stretched and fractured in the patient's vessel.According to the physician the subject coil may be affected by the stent cells.The physician has used a snare device using a micro guide wire and surgical sutures to remove most of the parts of the detached coil from the patient anatomy.The physician replaced it with a new device.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.During visual/microscopic inspection the main coil was returned with non-stryker microcatheter.There was significant amount of procedural fluids noted during the visual inspection.The main coil was found to be stretched.The suture and tip ball were found to be intact.The main coil was fond to be kinked/bent.Functional inspection: not required as the defect was confirmed.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 as reported code main coil stretched was confirmed based on the device analysis but as reported code main coil broken fracture/broken during use could not be confirmed.The device was returned, and the main coil had been detached from the delivery wire.It is probable that the main coil was detached within the microcatheter due to procedural or anatomical factors during use.An assignable cause of procedural factors will be assigned to the as reported and as analyzed main coil stretched as well as analyzed main coil prematurely detached/separated during use and main coil kinked/bent, 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.
Event or Problem Description
It was reported that stent-assisted endovascular aneurysmal coil embolization procedure was performed for acoma (anterior communicating artery) wide neck lobulated rupture aneurysm.The patient was reported to have moderately tortuous vascular anatomy.During the procedure guide catheter was placed to the right ica (internal carotid artery) c2 segment and the operator used guidewire for placing microcatheter at a2 for used.Then new microcatheter was placed to super selected to the lumen of aneurysm and aneurysmal coil embolization was performed.Stenting was performed to cover the neck of the aneurysm.When the operator tried to do coil embolization with the subject coil post stenting, while adjusting embolization before detachment, the subject coil stretched and fractured in the patient's vessel.According to the physician the subject coil may be affected by the stent cells.The physician has used a snare device using a micro guide wire and surgical sutures to remove most of the parts of the detached coil from the patient anatomy.The physician replaced it with a new device.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 5MM X 20CM
• 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: 12135676
• Report Number: 3008881809-2021-00292
• Device Sequence Number: 4166429
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: 04546540676511
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/03/2021

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: 10/08/2023
• Device Model Number: M0035475200
• Device Catalogue Number: M0035475200
• Device Lot Number: 22514559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/03/2021
• 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: NEUROFORM ATLAS STENT (STRYKER).; SL-10 MICRO CATHETER (STRYKER).; NEUROFORM ATLAS STENT (STRYKER); SL-10 MICRO CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 63 YR