MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422060
Medical Device Problem Codes	Expulsion (2933); Premature Separation (4045)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device remained implanted.
Event or Problem Description
It was reported that the subject coil was used for aneurysm located in the internal carotid artery (ica ) just below the anterior choroidal artery.During the procedure, a stent was deployed in the ica just below the anterior choroidal artery without any issues.When advancing the first coil, resistance was encountered inside the introducer sheath and was replaced with the subject coil.The subject coil was placed in the aneurysm without any issues and when the physician tried to detach the coil, the detachment system sounded 3 beeps which is an indication of detachment, but the subject coil was not detached.Withdrawing the delivery wire, a loop of the coil came out through the stent.When checking under fluoroscopy during removal of the delivery wire it was impossible to know that the coil was not detached since the microcatheter was within the coil mass.At this stage, the physician tried to push the delivery wire with the coil back into the aneurysm but unfortunately as the detachment zone had been weakened it detached leaving a loop in the ica.There was quite a delay to the procedure.The first one was trying to advance the coil through the sheath which took about 3 minutes and another minute to get another coil, prep and advance the second coil.Finally, there was approximately 5 minutes delay after the detachment system gave 3 beeps, but coil was not deployed, this is where the coil popped out into the aneurysm when removing the delivery wire.The physician had to take some time to discuss the next course of action but in the end the physician was happy to leave the subject coil as it was and wait to see if the coil would have any adverse effects upon follow up.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional testing could not be performed since the device was not returned for investigation.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.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.
Event or Problem Description
It was reported that the subject coil was used for aneurysm located in the internal carotid artery (ica ) just below the anterior choroidal artery.During the procedure, a stent was deployed in the ica just below the anterior choroidal artery without any issues.When advancing the first coil, resistance was encountered inside the introducer sheath and was replaced with the subject coil.The subject coil was placed in the aneurysm without any issues and when the physician tried to detach the coil, the detachment system sounded 3 beeps which is an indication of detachment, but the subject coil was not detached.Withdrawing the delivery wire, a loop of the coil came out through the stent.When checking under fluoroscopy during removal of the delivery wire it was impossible to know that the coil was not detached since the microcatheter was within the coil mass.At this stage, the physician tried to push the delivery wire with the coil back into the aneurysm but unfortunately as the detachment zone had been weakened it detached leaving a loop in the ica.There was quite a delay to the procedure.The first one was trying to advance the coil through the sheath which took about 3 minutes and another minute to get another coil, prep and advance the second coil.Finally, there was approximately 5 minutes delay after the detachment system gave 3 beeps, but coil was not deployed, this is where the coil popped out into the aneurysm when removing the delivery wire.The physician had to take some time to discuss the next course of action but in the end the physician was happy to leave the subject coil as it was and wait to see if the coil would have any adverse effects upon follow up.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11068726
• Report Number: 3008881809-2020-00402
• Device Sequence Number: 14172225
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 08/25/2023
• Device Model Number: M0035422060
• Device Catalogue Number: M0035422060
• Device Lot Number: 22401101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/24/2021
• 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: INZONE DETACHMENT SYSTEM (STRYKER); NEUROFORM ATLAS STENT (STRYKER); TARGET COIL (STRYKER)
• Outcome Attributed to Adverse Event: Other