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

Catalog Number	M0035442540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient.
Event or Problem Description
It was reported that during the coil embolization procedure, the part of the coil (subject device) was stuck in the tip of the microcatheter after detachment.Therefore, the physician attempted to use the guidewire to push the coil out from the tip of the microcatheter, but it did not work.Finally, the physician removed the microcatheter with inflating the balloon catheter at the neck of the aneurysm.However, part of the coil was protruded to the parent vessel.So, the physician fixed the hanging coil to the vessel wall with the stent.The procedure was completed successfully.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information available indicated that the device was confirmed to be in good condition prior to use.The reported event is covered in the device directions for use (dfu).The risk of the reported event has been addressed in the risk documentation and there are current controls in place to mitigate the risk of the as reported event.Based on the information currently available, the exact cause for the reported event cannot be determined.
Event or Problem Description
It was reported that during the coil embolization procedure, the part of the coil (subject device) was stuck in the tip of the microcatheter after detachment.Therefore, the physician attempted to use the guidewire to push the coil out from the tip of the microcatheter, but it did not work.Finally, the physician removed the microcatheter with inflating the balloon catheter at the neck of the aneurysm.However, part of the coil was protruded to the parent vessel.So, the physician fixed the hanging coil to the vessel wall with the stent.The procedure was completed successfully.

• Brand Name: TARGET 360 NANO 2.5 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8936407
• Report Number: 3008881809-2019-00253
• Device Sequence Number: 18964220
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: 07613252600305
• Combination Product (Y/N): N
• 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): 10/07/2019

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: 01/28/2022
• Device Catalogue Number: M0035442540
• Device Lot Number: 21179976
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/07/2019
• 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: BALLOON CATHETER (STRYKER); EXCELSIOR CATHETER (STRYKER); GUIDEWIRE (ASAHI); NEUROFORM STENT (STRYKER); BALLOON CATHETER (STRYKER); EXCELSIOR CATHETER (STRYKER); GUIDEWIRE (ASAHI); NEUROFORM STENT (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR