MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 3 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442030
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Stroke/CVA (1770); Occlusion (1984); Thrombosis (2100)
Date of Event	04/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of 2 reports submitted for the un-identified coil lot number that migrated to the m2.Subject device remains implanted.
Event or Problem Description
During repositioning of the coil into middle cerebral artery (mca) aneurysm, a portion of the coil stretched.It was reported that the stretched portion migrated to the m2 segment resulting in occlusion of the blood flow.The physician deployed an enterprise stent to secure the stretched portion against the vessel wall.In addition, urokinase (dose unknown) was arterial injected resulting in recanalization of blood flow.It was reported that post procedure a mild infarction was confirmed and additional urokinase (dose unknown) was administered.The physician indicated that during the procedure two coils were deployed; however, the physician could not determined which of the two coils (same size with different lot #) had partially migrated to the m2 segment.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 device was confirmed to be in good condition prior to use.Based on the information reported it is unclear which of the two coils used in the procedure migrated into the parent artery likely contributing to the patient¿s outcome.Therefore, the exact cause of the reported event cannot be determined.
Event or Problem Description
During repositioning of the coil into middle cerebral artery (mca) aneurysm, a portion of the coil stretched.It was reported that the stretched portion migrated to the m2 segment resulting in occlusion of the blood flow.The physician deployed an enterprise stent to secure the stretched portion against the vessel wall.In addition, urokinase (dose unknown) was arterial injected resulting in recanalization of blood flow.It was reported that post procedure a mild infarction was confirmed and additional urokinase (dose unknown) was administered.The physician indicated that during the procedure two coils were deployed; however, the physician could not determined which of the two coils (same size with different lot #) had partially migrated to the m2 segment.No further information is available.

• Brand Name: TARGET 360 NANO 2 MM X 3 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5772113
• Report Number: 3008881809-2016-00065
• Device Sequence Number: 225283
• Product Code: HCG
• UDI-Device Identifier: 07613252600312
• UDI-Public: (01)07613252600312(17)190131(10)18810270
• Combination Product (Y/N): N
• PMA/510(K) Number: K113412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2016

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: M0035442030
• Device Lot Number: 1881027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2016
• Supplement Report FDA Received Date: 09/22/2016
• 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: Other; Required Intervention