MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035466200
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure for left ica (internal carotid artery) aneurysm case, physician used microcatheter to insert subject coil.When inserting the subject coil, its was noted that the proximal portion had stretched during the framing in aneurysm and that the core wire had flowed to the distal part of the vessel.The physician tried to withdraw subject coil, but the proximal portion had fractured and was left behind upon removal.A snare device was used to retrieve the fractured fragment of subject coil and another coil was used to continue the procedure.The procedure was completed successfully and no clinical consequences were noted to the patient.
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the delivery wire and introducer sheath were kinked/bent and the delivery wire was noted to be broken/fractured.Functional inspection was not performed as the main coil was not returned.Due to the automated mes 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 was confirmed based on the damage noted to the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The available information indicates that the device was prepared as per the dfu, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The delivery wire was noted to be kinked and the introducer sheath was bent.It is probable that the introducer sheath and delivery wire were damaged during use, causing the delivery wire to fracture during use.An assignable cause of procedural factors will be assigned to the reported main coil stretched, main coil migration and main coil broken/fractured during use and to the analyzed coil delivery wire kinked/bent, coil introducer sheath kinked/bent, and coil delivery wire broken/fractured during use, 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 during the procedure for left ica (internal carotid artery) aneurysm case, physician used microcatheter to insert subject coil.When inserting the subject coil, its was noted that the proximal portion had stretched during the framing in aneurysm and that the core wire had flowed to the distal part of the vessel.The physician tried to withdraw subject coil, but the proximal portion had fractured and was left behind upon removal.A snare device was used to retrieve the fractured fragment of subject coil and another coil was used to continue the procedure.The procedure was completed successfully and no clinical consequences were noted to the patient.

• Brand Name: TARGET 360 STANDARD 6MM 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: 11499504
• Report Number: 3008881809-2021-00123
• Device Sequence Number: 3971745
• Product Code: HCG
• UDI-Device Identifier: 04546540676276
• UDI-Public: 04546540676276
• 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): 06/28/2021

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: 12/08/2022
• Device Model Number: M0035466200
• Device Catalogue Number: M0035466200
• Device Lot Number: 21993974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); SNARE (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 65