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

Catalog Number	M0035443060
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device was implanted.
Event or Problem Description
It was reported that during coil embolization of ruptured aneurysm in the anterior communicating artery (acom) during repositioning, the proximal section of the coil stretched, broke, and protruded from the aneurysm.There has been no re-intervention with stenting as of today.No additional information is available at this time.
Additional Manufacturer Narrative
Review of the manufacturing records did not reveal that the device failed to meet specifications upon release.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 coil embolization of ruptured aneurysm in the anterior communicating artery (acom) during repositioning, the proximal section of the coil stretched, broke, and protruded from the aneurysm.Re-intervention with stenting was performed several weeks later.The patient suffered no deficit.

• Brand Name: TARGET 360 NANO 3 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5760647
• Report Number: 3008881809-2016-00061
• Device Sequence Number: 455627
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: (01)07613252600329(17)190401(10)18809674
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2016

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: M0035443060
• Device Lot Number: 18809674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2016
• Supplement Report FDA Received Date: 09/23/2016
• 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