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

Model Number	M0035421030
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Sleep Dysfunction (2517)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
During one mca (middle cerebral artery) aneurysm embolization case, the operator placed the microcatheter to the child lumen of aneurysm and then inserted a subject coil.However, after detached the subject coil, the operator pulled the microcatheter to the parent lumen of aneurysm and during this process the subject coil stick to the microcatheter which led to part of the subject coil was brought into the vessel.The operator tried to deliver a guidewire through microcatheter to push the subject coil which was in the vessel to distal but failed and caused the surgical delay.Another microcatheter was used then placed to lower of mca and deployed a stent to press the coil to the vessel wall.Then continued the embolization and finished the procedure with another stent deployed to assist.After the procedure is completed, the patient experienced with sleepiness.Per physician¿s opinion, the sleepiness was caused by the subject coil protruding into the blood vessel affects blood flow.The patient is currently transferred to another hospital and is not clear about the current situation.
Event or Problem Description
During one mca (middle cerebral artery) aneurysm embolization case, the operator placed the microcatheter to the child lumen of aneurysm and then inserted a subject coil.However, after detached the subject coil, the operator pulled the microcatheter to the parent lumen of aneurysm and during this process the subject coil stick to the microcatheter which led to part of the subject coil was brought into the vessel.The operator tried to deliver a guidewire through microcatheter to push the subject coil which was in the vessel to distal but failed and caused the surgical delay.Another microcatheter was used then placed to lower of mca and deployed a stent to press the coil to the vessel wall.Then continued the embolization and finished the procedure with another stent deployed to assist.After the procedure is completed, the patient experienced with sleepiness.Per physician¿s opinion, the sleepiness was caused by the subject coil protruding into the blood vessel affects blood flow.The patient is currently transferred to another hospital and is not clear about the current situation.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be 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 the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was moderately tortuous, and an sl-10 and xt-17 microcatheter were used in the procedure in conjunction with the subject device.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 and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.

• 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12912480
• Report Number: 3008881809-2021-00503
• Device Sequence Number: 4640985
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: 04546540697974
• 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): 03/16/2022

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: 09/21/2023
• Device Model Number: M0035421030
• Device Catalogue Number: M0035421030
• Device Lot Number: 22460621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE (UNKNOWN MANUFACTURER); SL-10 MICROCATHETER (STRYKER); XT-17 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: Asian