MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that during wide neck irregular hemorrhagic aneurysm procedure on right posterior communicating artery (pcoma), the segment of the subject coil delivery wire was fractured at about 1 cm from the coil and the fractured part of the coil delivery wire was covered/pressed by the stent inside the aneurysm inside the patient's anatomy.The procedure was completed successfully and there were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that during wide neck irregular hemorrhagic aneurysm procedure on right posterior communicating artery(pcoma), the segment of the subject coil delivery wire was fractured at about 1 cm from the coil and the fractured part of the coil delivery wire was covered/pressed by the stent inside the aneurysm inside the patient's anatomy.The procedure was completed successfully and there were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added h4 manufacturing date ¿ added 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.Therefore, visual and functional analysis were not performed.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.Additional information provided by the customer indicated that no damage was noted to the packaging and continuous flush was maintained throughout the procedure.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, a cause of 'undeterminable' was assigned to the reported 'coil delivery wire broken/fractured during use'.
Additional Manufacturer Narrative
D3/h3 product available to stryker: updated.D10 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.H3 summary attached: updated.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.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.During the analysis of the returned device, it was revealed that the main coil was broken/fractured below the main coil junction.In addition, the proximal contact and delivery wire were found to be kinked due to handling damage.However, the delivery wire was not broken/fractured.A probable cause of procedural factors will be assigned to the reported and analyzed fracture, as the defect appears to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
It was reported that during wide neck irregular hemorrhagic aneurysm procedure on right posterior communicating artery(pcoma), the segment of the subject coil delivery wire was fractured at about 1 cm from the coil and the fractured part of the coil delivery wire was covered/pressed by the stent inside the aneurysm inside the patient's anatomy.The procedure was completed successfully and there were no reported clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 4MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9703581
• Report Number: 3008881809-2020-00039
• Device Sequence Number: 19539399
• Product Code: HCG
• UDI-Device Identifier: 04546540675927
• UDI-Public: 04546540675927
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Followup
• Report Date (Section B): 07/19/2020

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: 03/26/2022
• Device Model Number: M0035424080
• Device Catalogue Number: M0035424080
• Device Lot Number: 21326935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 07/08/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/04/2020; 07/19/2020
• 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 EZ STENT(STRYKER); XT-27 MICRO CATHETER(STRYKER)
• Patient Age: 72 YR