MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421520
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
During coil embolization of aneurysm located at the middle cerebral artery (mca) bifurcation, the coil was repositioned 2-3 times.The coil detached and confirmed through fluoroscopy.It was observed that 0.5cm of the coil was hanging out of the neck of the aneurysm and was found to be stretched.A stent was deployed in order to prevent the coil hanging in the vessel.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly, and performance specifications.Only the delivery wire was returned as the main coil remains implanted.No functional test could be performed on the returned device.The review and analysis of all available information failed to indicate an assignable cause.
Event or Problem Description
During coil embolization of aneurysm located at the middle cerebral artery (mca) bifurcation, the coil was repositioned 2-3 times.The coil detached and confirmed through fluoroscopy.It was observed that 0.5cm of the coil was hanging out of the neck of the aneurysm and was found to be stretched.A stent was deployed in order to prevent the coil hanging in the vessel.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 1.5MM X 2CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7967620
• Report Number: 3008881809-2018-00440
• Device Sequence Number: 13524313
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: 04546540697981
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 01/31/2021
• Device Catalogue Number: M0035421520
• Device Lot Number: 20264539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: 48 YR