MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3.5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035473510
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the coil embolization procedure, it was reported that the first coil (subject device) was implanted successfully.Then second coil encountered resistance when advancing in the distal tip of microcatheter and was removed.And then the third coil also encountered resistance when advancing in the distal tip of the microcatheter and the physician decided to remove it.However, during the removal of the third coil, the first coil was somehow being retracted into the microcatheter and everything got stuck.Therefore, the physician decided to remove the microcatheter and hoping the coils would come with the microcatheter together.Unfortunately, the first coil was loose from the microcatheter and part of the coil was protruded to the parent vessel.Finally, the physician removed the first coil from the patient with the stent retriever after several attempts.Thus, the procedure was stopped, and the patient was going to be surgically clipped instead of coiling.No clinical consequences reported to the patient.No further information is available for now.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.This complaint appears to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu (direction for use), but performance was limited due to procedural factors during use.Therefore an assignable cause of cause traced to component failure will be assigned to the reported event.
Event or Problem Description
During the coil embolization procedure, it was reported that the first coil (subject device) was implanted successfully.Then second coil encountered resistance when advancing in the distal tip of microcatheter and was removed.And then the third coil also encountered resistance when advancing in the distal tip of the microcatheter and the physician decided to remove it.However, during the removal of the third coil, the first coil was somehow being retracted into the microcatheter and everything got stuck.Therefore, the physician decided to remove the microcatheter and hoping the coils would come with the microcatheter together.Unfortunately, the first coil was loose from the microcatheter and part of the coil was protruded to the parent vessel.Finally, the physician removed the first coil from the patient with the stent retriever after several attempts.Thus, the procedure was stopped, and the patient was going to be surgically clipped instead of coiling.No clinical consequences reported to the patient.No further information is available for now.

• Brand Name: TARGET 360 SOFT 3.5MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8204952
• Report Number: 3008881809-2018-00554
• Device Sequence Number: 16571641
• Product Code: HCG
• UDI-Device Identifier: 04546540714770
• UDI-Public: 04546540714770
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 02/20/2019

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: 06/23/2021
• Device Catalogue Number: M0035473510
• Device Lot Number: 20663621
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 02/17/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/20/2019
• 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: SL-10 MICROCATHETER (STRYKER); TARGET COIL (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR