MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423060
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device remains implanted.
Event or Problem Description
It was reported that during a coil embolization of an aneurysm located in the anterior communicating (acom) artery, the second coil detached unexpectedly while being repositioned.The physician did not remove the coil because a retrieval device was not available; however, an un-specified treatment was administered and the procedure was terminated.The physician indicated that steroid will be administered to the patient if there is headache complaints.No further information is available.
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.Information available indicated that the aneurysm location was too angled and the physician couldn't avoid twisting the microcatheter and coil delivery wire; which, lead to detachment.Based on this information an assignable cause of operational context was assigned to this event.
Event or Problem Description
It was reported that during a coil embolization of an aneurysm located in the anterior communicating (acom) artery, the second coil detached unexpectedly while being repositioned.The physician did not remove the coil because a retrieval device was not available; however, an un-specified treatment was administered and the procedure was terminated.The physician indicated that steroid will be administered to the patient if there is headache complaints.No further information is available.

• Brand Name: TARGET 360 ULTRA 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5756466
• Report Number: 3008881809-2016-00057
• Device Sequence Number: 16145167
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: (01)04546540675880(17)190131(10)18808970
• Combination Product (Y/N): N
• PMA/510(K) Number: K102672
• 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): 06/04/2016

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: 01/31/2019
• Device Catalogue Number: M0035423060
• Device Lot Number: 18808970
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2016
• Supplement Report FDA Received Date: 09/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR