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

Catalog Number	M0035422540
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a stent assisted coiling procedure, the coil (subject device) became entangled with existing coil mass and was not able to be removed.It was reported the coil stretched, was protruding from the aneurysm and broke.A second stent was used to push the coil at the vessel wall.There was no clinical consequence to the patient as a result of this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device noted damage to the device but the reported coil break cannot be confirmed as no break was observed.The delivery wire was kinked, likely due to handing, and the main coil was kinked and stretched; functional testing could not be performed due to the condition of the returned device.It is likely the coil was damaged while advancing and/or repositioning during the procedure and was perceived to be broken due to the damages noted.Although the reported coil break is not confirmed, based on the information available and device analysis, the reported event (coil damage and protrusion) was likely due to procedural/anatomical factors encountered during the procedure; cause traced to component failure is assigned to this event.
Event or Problem Description
During a stent assisted coiling procedure, the coil (subject device) became entangled with existing coil mass and was not able to be removed.It was reported the coil stretched, was protruding from the aneurysm and broke.A second stent was used to push the coil at the vessel wall.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET 360 ULTRA 2.5MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7643832
• Report Number: 3008881809-2018-00285
• Device Sequence Number: 14056711
• Product Code: HCG
• UDI-Device Identifier: 04546540675866
• UDI-Public: 04546540675866
• 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): 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: M0035422540
• Device Lot Number: 20104499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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: NEUROFORM ATLAS STENT (STRYKER, 1 OF 2); NEUROFORM ATLAS STENT (STRYKER, 2 OF 2); SL-10 MICROCATHETER (STRYKER)