MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035442040
Medical Device Problem Codes	Expulsion (2933); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
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.Visual and functional inspections were not performed due to the device was not returned to the manufacturer.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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that preparation/set-up was performed as per the dfu, continuous flush was maintained for the duration of the procedure, there was no thrombus or any other embolic agents present on the coil detachment zone, the delivery wire and microcatheter markers were verified to be properly aligned under fluoroscopy, the power supply was maintained in a stable position, and the coil detached fully after the microcatheter was manipulated following the initial detachment attempt with the power supply.The procedure was completed by leaving the coil as is with about 20% of the coil hanging in the parent vessel (a1/a2 portion of the anterior cerebral artery (aca)).The coil was attempted to be removed with a snare, but due to the anatomy it could not be tracked up and the coil was unable to be snared out.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the subject coil was attempted to be detached using the power supply, but the subject coil did not fully detach.The physician noticed this as he pulled back on the delivery wire to ensure detachment.Following this, after microcatheter movements, the coil detached fully without an additional attempt to detach with the power supply.This left a portion of the coil protruding into the parent vessel.The physician attempted to retrieve the coil with the snare but was unsuccessful and left the coil with partial tail hanging into the parent vessel (anterior cerebral artery).No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 2MM X 4CM
• 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: 17001042
• Report Number: 3008881809-2023-00267
• Device Sequence Number: 7126068
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: 07613252600299
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/25/2023

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: 11/18/2023
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 22590395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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: INZONE POWER SUPPLY (STRYKER); MICROCATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown