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

Catalog Number M0035442540

Device Problems Migration (4003); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2024

Event Type  Injury  

Event 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.

Manufacturer Narrative

H3 other text : device is implanted in the patient.

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 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
• Type of Device: 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
• MDR Text Key: 338935039
• Report Number: 3008881809-2024-00135
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: 07613252600305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0035442540
• Device Lot Number: 24259810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENVOY DA GUIDE SHEATH (UNKNOWN).; INZONE DETATCHER (STRYKER).; SL-10 MICROCATHETER (STRYKER).; TARGET COIL (STRYKER).
• Patient Outcome(s): Required Intervention