MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442540
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a neurovascular procedure when the subject coil was attempted to detached using the power supply system, the power supply system gave three beeps to signal detachment.When the physician pulled back the subject coil, it was still attached to the subject coil delivery wire.While the physician pulled back the subject coil, the subject coil interacted with an already implanted coil and pulled a loop from the already implanted coil out into the parent artery.When the physician attempted to re-advance the subject coil he did not like how it looked so he pulled back on the subject coil to adjust.When the physician pulled back the subject coil for the second time, the subject coil prematurely detached and the tail of the subject coil was left in the in the in the microcatheter.At this point the physician used the subject coil pusher wire to push the tail of the subject coil out of the microcatheter.Through this whole process two coil loops were left in each a2 artery.The procedure was aborted and patient was put on dual antiplatelet therapy overnight.The next day stents were used to tack down the two coil loops left in each a2 artery and the issue was resolved.
Additional Manufacturer Narrative
H3 other text : device is implanted in the patient.
Additional Manufacturer Narrative
1/2 report.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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.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.Per the event description the main coil was not detached as expected and during an attempt to retrieve the coil it interacted with the coil mass and during repositioning the coil detached.As the coil was the last of 8 coils placed, it may have been possible that the detachment zone (dz) was in contact with the coil mass which may have impacted detachment, resulting in the subsequent events.Its likely that the coil partially detached electrolytically and when repositioning the coil, the remainder of the dz broke off.However as the device has not been returned this cannot be confirmed.While there are a number of potential causes for the reported issues, because a 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 the as reported main coil prematurely detached/separated during use', 'main coil false detachment signal', 'main coil protrusion'.
Event or Problem Description
It was reported that during a neurovascular procedure when the subject coil was attempted to detached using the power supply system, the power supply system gave three beeps to signal detachment.When the physician pulled back the subject coil, it was still attached to the subject coil delivery wire.While the physician pulled back the subject coil, the subject coil interacted with an already implanted coil and pulled a loop from the already implanted coil out into the parent artery.When the physician attempted to re-advance the subject coil he did not like how it looked so he pulled back on the subject coil to adjust.When the physician pulled back the subject coil for the second time, the subject coil prematurely detached and the tail of the subject coil was left in the in the in the microcatheter.At this point the physician used the subject coil pusher wire to push the tail of the subject coil out of the microcatheter.Through this whole process two coil loops were left in each a2 artery.The procedure was aborted and patient was put on dual antiplatelet therapy overnight.The next day stents were used to tack down the two coil loops left in each a2 artery and the issue was resolved.

• Brand Name: TARGET 360 NANO 2.5MM 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: 19005432
• Report Number: 3008881809-2024-00135
• Device Sequence Number: 8445727
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: 07613252600305
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 04/15/2024

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: 03/27/2026
• Device Catalogue Number: M0035442540
• Device Lot Number: 24259810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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: ENVOY DA GUIDE SHEATH (UNKNOWN).; INZONE DETATCHER (STRYKER).; SL-10 MICROCATHETER (STRYKER).; TARGET COIL (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown