MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423100
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during stage ii of stent-assisted coil embolization of a giant partially thrombosed anterior communicating artery (acoma) aneurysm, the subject coil kicked out the microcatheter from the aneurysm.The coil was pulled back and while being retrieved, broke with some of the coil remaining in the aneurysm and protruding halfway into the internal carotid artery (ica).Attempts to remove the coil resulted in further stretching of the coil into the ica.First attempt to remove the coil by snare device was unsuccessful and the detached coil advanced into the intracavernous segment of the ica.The coil was eventually removed after 2nd snare device technique with no apparent complications.Procedure was considered finished at this point with only a small sliver of aneurysm neck remnant.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed; therefore a cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during stage ii of stent-assisted coil embolization of a giant partially thrombosed anterior communicating artery (acoma) aneurysm, the subject coil kicked out the microcatheter from the aneurysm.The coil was pulled back and while being retrieved, broke with some of the coil remaining in the aneurysm and protruding halfway into the internal carotid artery (ica).Attempts to remove the coil resulted in further stretching of the coil into the ica.First attempt to remove the coil by snare device was unsuccessful and the detached coil advanced into the intracavernous segment of the ica.The coil was eventually removed after 2nd snare device technique with no apparent complications.Procedure was considered finished at this point with only a small sliver of aneurysm neck remnant.

• Brand Name: TARGET 360 ULTRA 3MM 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: 6074094
• Report Number: 3008881809-2016-00240
• Device Sequence Number: 868327
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: (01)04546540675903(17)190531(10)19069474
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K112385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2017

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: 05/31/2019
• Device Catalogue Number: M0035423100
• Device Lot Number: 19069474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 01/18/2017
• 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: ATLAS STENT (STRYKER); EXCELSIOR MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR