MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035423080
Medical Device Problem Codes	Expulsion (2933); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that during embolization procedure at posterior communicating artery, the subject coil protruded to parent vessel, the physician tried to adjust the coil several times and the proximal area of the coil got stretched, then the physician tried to withdraw the coil and found the coil was prematurely detached.The physician used a guidewire to guide microcatheter to pass the lesion and deployed a stent to press the stretched coil.The guidewire was unable to advance even after twisted to adjust.The physician withdrew the guidewire and found it fractured.Then the physician used a snare device to take the detached coil (subject device) and along with the guidewire and completed the procedure successfully.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.The subject device was not returned.Therefore, visual and functional analysis were not performed.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.Additional information provided by the customer indicated the device prepared for use as per the directions for use and no damage noted to the packaging prior to opening the packaging.Also, continuous flush set up and maintained throughout the clinical procedure.It is most likely that anatomical or procedural factors resulted the coil protruded to parent vessel and eventually detached when trying to remove.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 event.
Event or Problem Description
It was reported that during embolization procedure at posterior communicating artery, the subject coil protruded to parent vessel, the physician tried to adjust the coil several times and the proximal area of the coil got stretched, then the physician tried to withdraw the coil and found the coil was prematurely detached.The physician used a guidewire to guide microcatheter to pass the lesion and deployed a stent to press the stretched coil.The guidewire was unable to advance even after twisted to adjust.The physician withdrew the guidewire and found it fractured.Then the physician used a snare device to take the detached coil(subject device) and along with the guidewire and completed the procedure successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 3MM 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: 10018121
• Report Number: 3008881809-2020-00125
• Device Sequence Number: 19355099
• Product Code: HCG
• UDI-Device Identifier: 04546540675897
• UDI-Public: 04546540675897
• 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
• Report Date (Section B): 05/14/2020

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: 05/21/2022
• Device Model Number: M0035423080
• Device Catalogue Number: M0035423080
• Device Lot Number: 21455586
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 05/14/2020
• 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); SYNCHRO GUIDEWIRE(STRYKER); XT-27 MICROCATHETER(STRYKER); NEUROFORM EZ STENT(STRYKER); SYNCHRO GUIDEWIRE(STRYKER); XT-27 MICROCATHETER(STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR