MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 4MMX10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035464100
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	09/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has been implanted.
Event or Problem Description
It was reported that during an embolization procedure that the subject device was observed to be broken.The physician decided to retract the coil together with the microcatheter, but half of the coil remained in the arterial lumen.Medical intervention was performed through a double antiaggregation procedure and a stent was deployed to keep the coil against the arterial wall.The coil was maintained in place against the arterial wall and the procedure was completed.There was no clinical consequences reported due to this event.The patient was reported to be in good condition.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The cause of the reported issue could not be definitively determined.
Event or Problem Description
It was reported that during an embolization procedure that the subject device was observed to be broken.The physician decided to retract the coil together with the microcatheter, but half of the coil remained in the arterial lumen.Medical intervention was performed through a double antiagregation procedure and a stent was deployed to keep the coil against the arterial wall.The coil was maintained in place against the arterial wall and the procedure was completed.There was no clinical consequences reported due to this event.The patient was reported to be in good condition.

• Brand Name: TARGET 360 STANDARD 4MMX10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6059515
• Report Number: 3008881809-2016-00235
• Device Sequence Number: 422269
• Product Code: HCG
• UDI-Device Identifier: 04546540676221
• UDI-Public: (01)04546540676221(17)180831(10)18541669
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K093142
• 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): 09/30/2016

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: 08/31/2018
• Device Catalogue Number: M0035464100
• Device Lot Number: 18541669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2016
• Supplement Report FDA Received Date: 12/08/2016
• 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: 56 YR
• Patient Weight: 50